Methods and devices for performing electrical stimulation to treat various conditions

ABSTRACT

In certain variations, systems and/or methods for electromagnetic induction therapy are provided. One or more ergonomic or body contoured applicators may be included. The applicators include one or more conductive coils configured to generate an electromagnetic or magnetic field focused on a target nerve, muscle or other body tissues positioned in proximity to the coil. One or more sensors may be utilized to detect stimulation and to provide feedback about the efficacy of the applied electromagnetic induction therapy. A controller may be adjustable to vary a current through a coil to adjust the magnetic field focused upon the target nerve, muscle or other body tissues based on the feedback provide by a sensor or by a patient. In certain systems or methods, pulsed magnetic fields may be intermittently applied to a target nerve, muscle or tissue without causing habituation.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/676,635 filed Apr. 1, 2015 (now U.S. Pat. No. 9,387,338issued. Jul. 12, 2016), which is a continuation of U.S. patentapplication Ser. No. 14/085,639 filed Nov. 20, 2013 (now U.S. Pat. No.9,002,477 issued Apr. 7, 2015), which is a continuation of U.S. patentapplication Ser. No. 13/456,016 filed Apr. 25, 2012 (now Abandoned),which is a continuation of PCT International Patent Application NumberPCT/US2010/054167, filed Oct. 26, 2010, which claims benefit of priorityto U.S. Provisional Patent Application Ser. No. 61/279,883 filed Oct.26, 2009. Each of the above referenced applications is incorporatedherein by reference in their entirety. U.S. patent application Ser. No.14/085,639 filed Nov. 20, 2013, is also a continuation-in part of U.S.patent application Ser. No. 12/508,529 filed Jul. 23, 2009 (nowAbandoned), which is a continuation-in-part of U.S. patent applicationSer. No. 11/866,329 filed Oct. 2, 2007 (now Abandoned), which claimspriority to U.S. Provisional Patent Application Ser. No. 60/848,720filed Oct. 2, 2006. Each of the above referenced applications isincorporated herein by reference in their entirety.

The following applications are also incorporated herein by reference intheir entirety for all purposes: U.S. patent application Ser. No.12/508,529 filed Jul. 23, 2009, which is a continuation in part of U.S.patent application Ser. No. 11/866,329 filed Oct. 2, 2007, which claimspriority to U.S. Provisional Patent Application Ser. No. 60/848,720filed Oct. 2, 2006; U.S. patent application Ser. No. 12/695,087 filedJan. 27, 2010, which is a continuation of U.S. patent application Ser.No. 11/332,797 filed Jan. 17, 2006; U.S. patent application Ser. No.12/509,362 filed Jul. 24, 2009; Ser. No. 12/469,365 filed May 20, 2009which is a continuation of U.S. patent application Ser. No. 11/866,329filed Oct. 2, 2007 which claims priority to U.S. Provisional PatentApplication Ser. No. 60/848,720 filed Oct. 2, 2006, and Ser. No.12/469,625 filed May 20, 2009 which is a continuation of U.S. patentapplication Ser. No. 11/866,329 filed Oct. 2, 2007 which claims priorityto U.S. Provisional Patent Application Ser. No. 60/848,720 filed Oct. 2,2006; and Ser. No. 12/509,304 filed Jul. 24, 2009 which is acontinuation of U.S. patent application Ser. No. 12/508,529 filed Jul.23, 2009 which is a continuation-in-part of U.S. patent application Ser.No. 11/866,329 filed Oct. 2, 2007 which claims priority to U.S.Provisional Patent Application Ser. No. 60/848,720 filed Oct. 2, 2006;and Ser. No. 12/509,345 filed Jul. 24, 2009 which is a continuation ofU.S. patent application Ser. No. 12/508,529 filed Jul. 23, 2009 which isa continuation-in-part of U.S. patent application Ser. No. 11/866,329filed Oct. 2, 2007 which claims priority to U.S. Provisional PatentApplication Ser. No. 60/848,720 filed Oct. 2, 2006.

BACKGROUND

The concept of pulsed electromagnetic stimulation (PES) was firstobserved by the renowned scientist Michael Faraday in 1831. Faraday wasable to demonstrate that time varying, or pulsed electromagnetic fieldshave the potential to induce current in a conductive object. Faraday'sexperimental setup was simple. He found that by passing strong electriccurrent through a coil of wire he was able to produce pulsedelectromagnetic stimuli. This pulsed electromagnetic stimulus was ableto induce the flow of current in a nearby electrically conductive body.

In the years since the discoveries of Faraday, pulsed electromagneticstimulators have found application in countless areas of scientificinvestigation. In 1965, the scientists Bickford and Freming demonstratedthe use of electromagnetic stimulation to induce conduction withinnerves of the face. Later, in 1982 Polson et al., U.S. Pat. No.5,766,124 produced a device capable of stimulating peripheral nerves ofthe body. This device was able to stimulate peripheral nerves of thebody sufficiently to cause muscle activity, recording the first evokedpotentials from electromagnetic stimulation.

One of the earliest practical applications of electromagneticstimulating technology took the form of a bone growth stimulator—adevice that employed low frequency pulsed electromagnetic fields (PEMF)to stimulate bone repair. They first found use approximately 20 yearsago in the treatment of non healing fractures, and are slowly becomingthe standard of care for this condition.

As investigators have studied the effects of electromagnetic fields onfracture healing, it has been demonstrated that PEMFs can not onlyfacilitate fracture healing but also promote numerous other positiveeffects on the human body, including: (1) causing muscles to contract,(2) altering nerve signal transmission to decrease experienced pain, and(3) causing new cell growth in cartilage. These powerful effects ofpulsed electromagnetic stimulation have been well established inlaboratory studies of animal models and also in multiple large, doubleblind, placebo controlled studies of human subjects published in themedical literature.

Erickson's U.S. Pat. No. 5,181,902, Jan. 26, 1993, which describes adevice using a double transducer system with contoured, flat woundtransducers intended to generate therapeutic flux-aided electromagneticfields in the body. The device is suggested to be conformed to thecontour of the patient's back and incorporates an adjustable belt intothe design. This system, as it is described, is disadvantageous in atleast two respects. First, the flat, wound nature of the coil in thisdevice is limited in its delivery of pulsed electromagnetic fields todeep tissues of the body. Second, the rigid nature of this device,intended to provide bracing for patients recovering from spinal fusionsurgeries, may prove uncomfortable to some patients, especially indelivering therapy to regions of the body other than the back, such asthe knee, elbow, hand, or other joints and tissues.

U.S. Pat. No. 6,086,525, which discloses a device that has a single coilin the shape of a “C” where the intensity of the electromagnetic fieldis between the ends of the “C”. That point must be employed directlyover the target nerve or muscle to be stimulated. The coil is toroidalin configuration and utilizes a unique core of vanadium permendur in thepreferred form. One of the disadvantages of this device is that itrequires a trained technician to treat the patient and to properly handhold the open end of the “C” over the targeted nerve or muscle to bestimulated. The device is not portable and is designed for use inhospitals or similar institutions. Also the vanadium permendur core isrequired to increase the strength of the electromagnetic field to bestrong enough to be effectively used. The design, shape andconfiguration described in Davey and other prior art devices, requirethe electromagnetic stimulator to be hand operated during use.

Tepper in U.S. Pat. No. 5,314,401, May 24, 1994 describes a pulsedelectromagnetic field transducer that is intended to be conformable tothe contour of a patients body. The PEMF transducer in this applicationis described as having a desired form and sufficient rigidity tomaintain an anatomical contour. This system is disadvantageous in anumber of respects. First, the desired contouring of this device willrequire that a significant number of different sizes be manufactured toaccommodate the contours of an endless variety of body shapes. Second,the intended device does not incorporate markings to ensure that thedevice is placed in a correct alignment over the targeted area of thebody. Finally, this proposed device utilizes flat, wound coils,providing PEMFs that do not penetrate as deeply or as uniformly intobody tissues as those fields produced by solenoid coils.

In U.S. Pat. No. 6,179,770 B1, Jan. 30, 2001, Mould describes dual coilassemblies in a magnetic stimulator for neuro-muscular tissue, withcooling provided for the transducer coil. This device is intended to beheld by a trained user over the targeted regions of the body in order todeliver PEMF therapy. The design of this device is limited by thedifficult nature of manipulating a single coil and the cost-intensiverequirement of using highly skilled medical personnel for operation.

Parker in U.S. Pat. No. 6,155,966, Dec. 5, 2000 describes a wearablearticle with a permanent magnet/electromagnet combination device to beused for toning tissue with focused, coherent EMF. This device isdisadvantageous in several respects. First, this device is intended tobe a hand-held application, with the user applying the device totargeted areas of the body. The hand-held nature of this applicationcreates an inherently inconsistent and non-uniform method for delivery,especially difficult with the intention of the device to provide afocused electromagnetic stimulus. Second, the device combines a staticmagnet with the electromagnet assembly in an attempt to create aunipolar, negative polarity field. This form of electromagnetic fieldstimulation has not been demonstrated to be effective in the treatmentof osteoarthritis, musculoskeletal pain, or atrophy treatment.

March's U.S. Pat. No. 6,200,259 B1, Mar. 13, 2001 describes a devicewith electromagnetic field coils applied front and back to a patient fortreating cardiovascular disease by angiogenesis. An EMF dosage plancontemplates, multiple coil implants and pulse variables includingcarrier frequency, pulse shape, duty cycle, and total time exposed. Thisdevice describes the placement of coils around the regions of tissues inwhich collateralization of blood flow (or angiogenesis) is desired. Thedesign contemplates applications including the use of coils embedded ina cloth wrap, which could be worn as a garment surrounding the body areaof interest. Alternatively, an applicator with embedded coils to beplaced around an arm or a leg to deliver the desired field is described.The use of PEMF in this application for the purpose of modulation ofangiogenesis shows significant promise. The description of this device,however, does not suggest any extension of the electromagneticphenomenon in circumstances where PEMF stimulation can provide dramaticopportunities for the treatment of osteoarthritis, and musculoskeletalpains including tendonitis, bursitis, and muscle spasms. Furthermore,this device is disadvantageous in the fact that it does not provide forthe use of solenoid-type coils for the delivery of PEMF.

Poison's U.S. Pat. No. 5,766,124, Jun. 16, 1998 describes a magneticstimulator of neuro-muscular tissue. A reserve capacitor providing moreefficiency in the control circuitry is devised. The description of thedevice, however, describes the stimulating coil in broad, generic terms,and does not contemplate application of the coil in any type of bodyapplicator or other specific method for delivering PEMF to targetedareas of the body. As a result, this device is disadvantageous, in therespect that is does not provide for any method or delivery system toprovide consistent uniform PEMF stimulation.

Schweighofer's U.S. Pat. No. 6,123,658, Sep. 26, 2000 describes amagnetic stimulation device which consists of a stimulation coil, ahigh-voltage capacitor, and a controllable network part. This device isintended to differentiate itself from low-voltage, low current devicesby using a specific high-voltage, high current design to deliver PEMFfor the purpose of triggering action potentials in deep neuromusculartissue. This coil in this device is described as having a difficult andexpensive to use hand-held configuration.

Lin in U.S. Pat. No. 5,857,957, issued Jan. 12, 1999 teaches the use offunctional magnetic stimulation for the purpose of inducing a coughfunction in a mammalian subject. The description of the device providesfor the use of hand-held stimulation coil, intended to be placed overthe anterior chest of the subject for the purpose of stimulating nervesto induce a cough. This system is disadvantageous in the requirement ofhand-held delivery which is difficult and inconsistent. The descriptioncontemplates use of the device in the induction of cough, and does notcontemplate extension of the use of the device into other areas ofneuromuscular stimulation.

Tepper in U.S. Pat. No. 6,024,691, issued Feb. 15, 2000 describes acervical collar with integral transducer for PEMF treatment. Thedescription of this device provides for the use of a single coiltransducer, formed into the shape of a cervical collar. This system isdisadvantageous in several respects. First, this device does not providefor the use of solenoid-type coils in the delivery of PEMF, which canprovide a uniform and consistent signal. Second, the semi-rigid designof the collar complicates the delivery of PEMF to persons of differingbody sizes. That is, for a person with a larger than average (or smallerthan average) size neck, the design and semi-rigid nature of the devicewould make an exacting fit difficult, thereby diminishing theeffectiveness of any delivered therapy. Furthermore, this device isdesigned to immobilize the neck and is therefore not applicable to mostpatients. Lastly, the device must be lowered over the head makingapplication difficult.

Erickson in U.S. Pat. No. 5,401,233, issued Mar. 28, 1995 describes aneck collar device for the delivery of PEMF therapy. The description ofthis device provides for the use of semi-rigid transducers, intended tobe conformable to a selected anatomical contour. This device indisadvantageous in respects similar to those of Pollack U.S. Pat. No.5,401,233, in that the device does not provide for the use ofsolenoid-type coils. Furthermore, this device, is intended to providebracing (as might be necessary for the treatment of fractures or aftersurgery). As a result, the rigidity of the device necessary to serve thebracing function makes the device less comfortable to wear, especiallyfor a person who would not require bracing (such as in the treatment ofarthritis, muscle spasm, or other forms of musculoskeletal pain).

Kolt in U.S. Pat. No. 5,518,495, issued May 21, 1996 describes a coilwound on a large bobbin that permits the insertion of an arm or a leginto the field of the coil for PEMF type therapy. This device isdisadvantageous in several respects. First, the described use of abobbin, around which the wire for the stimulating coil is wound providesfor the treatment of certain areas of the body, but is certainly limitedin its ability to deliver therapy to areas of the body such as the hips,shoulder, back, neck, etc. That is, the constraints of our human anatomymake it nearly impossible to approximate a metal bobbin, and thus thestimulating coil, to regions of the body such as the ball and socketjoints of the hip or shoulder, where the round metal bobbin would strikethe torso before it allowed the stimulating coils to adequately blanketwith therapy the arm and/or joint in the hip and shoulder. Similarly,the use of a metal bobbin for the delivery of PEMF stimulation to theback would necessitate a large, cumbersome delivery system (into whichthe entire body would have to fit) in order to adequately deliverstimulation to targeted areas on the back or torso. Second, the deviceis described as a rigid bobbin through which the extremity is placed.This format makes application more difficult in that the applicatorcannot be worn and therefore does not provide for consistent idealplacement of the extremity to maximize field effects. In fact, mostdesigns of a similar nature are clinic-based, devices and, therefore,would not be amenable to home healthcare applications as with thecurrent invention. Third, the device described magnetic field within thebobbin is intended to have a maximum magnetic flux density in the rangeof 4.5 to 6 gauss. Studies (such as Trock et al in the Journal ofRheumatology 1994; 21(10): 1903-1911) have shown that PEMF stimulationin the range of 15-25 or more gauss are effective in the treatment ofosteoarthritis or other musculoskeletal pain conditions.

Pollack in U.S. Pat. No. 5,014,699, issued May 14, 1991 describes a coilwound around the cast on an appendage for the delivery of PEMF treatmentto fractured bone. The described device has shown promise for thetreatment of fractured bone, especially nonunion or delayed healingfractures. However, the description of the device does not provide forextension of this application to the treatment of other conditions, suchas arthritis, musculoskeletal pain, or atrophy.

Imran in US Pat App No 2006/0052839 filed Sep. 7, 2005 describe the useof an implantable stimulator for the treatment of chronic back pain.While this modality may be effective at treating back pain, it requiresa major surgery and will eventually suffer from habituation as the areaaround the needle fibroses and the nerve becomes deadened to repeatedstimulation.

SUMMARY

In certain variations, systems for electromagnetic induction therapy mayinclude one or more conductive coils disposed within or along anapplicator. The coils may be configured to generate a magnetic fieldfocused on a target nerve, muscle or other body tissues in proximity tothe coil. One or more sensors may be utilized to detect electricalconduction in the target nerve, to detect a muscular response caused byan electrical conduction in the target nerve, or to detect stimulationof a nerve, muscle or other body tissues and to provide feedback aboutthe efficacy of the applied electromagnetic induction therapy. Acontroller in communication with the sensor may be adjustable to vary acurrent through the at least one coil so as to adjust the magnetic fieldfocused upon the target nerve, muscle or other body tissues. Optionally,a user or patient may detect stimulation of a nerve, muscle or bodytissue and the therapy may be adjusted based on feedback from the useror patient.

In certain variations, the applicator may be configured tointermittently apply or deliver pulsed magnetic fields to a targetnerve, muscle or tissue without causing habituation of the target nerve,muscle or tissue.

In certain variations, methods of electromagnetic induction therapy mayinclude one or more of the following steps. A first portion of apatient's body may be positioned relative to or in proximity to anapplicator or an applicator may be positioned relative to or inproximity to a first portion of a patient's body, such that a targetnerve, muscle or tissue within the first portion of the body is inproximity to one or more conductive coils disposed within or along theapplicator. A current may be passed through a coil to generate amagnetic field focused on the target nerve, muscle or tissue. Anelectrical conduction through the target nerve, a muscular responsecaused by an electrical conduction through the target nerve orstimulation of a nerve, muscle, or body tissue may be detected by asensor positioned along a second portion of the body. A signal from thesensor indicative of the electrical conduction or stimulation may bereceived, which provides feedback about the efficacy of the appliedelectromagnetic induction therapy. The current may be adjusted by acontroller in communication with the conductive coils based on thefeedback.

Optionally, a user may detect stimulation of a nerve, muscle or bodytissue and the therapy may be adjusted based on feedback from the user.In certain variations, pulsed magnetic fields may be intermittentlyapplied or delivered a target nerve, muscle or tissue without causinghabituation of the target nerve, muscle or tissue. Such intermittentmagnetic fields may be used to treat chronic conditions, e.g., chronicpain, without causing habituation.

In certain variations, applicators may be ergonomic or may be designedor configured to accommodate, approximate or be positioned relative toor in proximity to specific regions of the body or anatomy. The specificregions of the body or anatomy may be positioned relative to theapplicators, or the applicators may be positioned relative to thespecific regions of the body or anatomy to treat various conditions, forexample, osteoarthritis, arthritis, back or neck pain, atrophy orparalysis, chronic pain, phantom or neuropathic pain, neuralgia,migraines, orthopedic conditions.

Other features and advantages will appear hereinafter. The features andelements described herein can be used separately or together, or invarious combinations of one or more of them.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings constitute a part of this specification and includeexemplary embodiments of the invention, which may be embodied in variousforms. It is to be understood that in some instances various aspects ofthe embodiments may be shown exaggerated or enlarged to facilitate anunderstanding of the embodiments.

FIG. 1 is a schematic view of an apparatus for magnetic inductiontherapy according to a first variation.

FIG. 2 is a schematic view of an apparatus for magnetic inductiontherapy according to a second variation.

FIG. 3 is a schematic view of an apparatus for magnetic inductiontherapy according to a third variation.

FIG. 4 is a schematic view of an apparatus for magnetic inductiontherapy according to a fourth variation.

FIG. 5 is a schematic view of an apparatus for magnetic inductiontherapy according to a fifth variation.

FIGS. 6A-6D are schematic illustrations depicting a first method of useof an apparatus for magnetic induction therapy. This method is based onadjusting the position of the conductive coils so to optimize a magneticflow applied to a target nerve.

FIGS. 7A-7D are schematic illustrations of a second method of use of anapparatus for magnetic induction therapy. This method is based onlocking the conductive coils in position once electrical conduction in atarget nerve has been detected.

FIG. 8 is a schematic view of a variation that includes a plurality ofsensors.

FIGS. 9A-9D are schematic representations of different garments adaptedto operate as apparatus for magnetic induction therapy.

FIG. 10 is a schematic view of an apparatus for providing electricalstimulation.

FIG. 11 is a schematic view of another variation of an apparatus forproviding electrical stimulation.

FIG. 12 shows a schematic view of an energy emitting system including amicroneedle patch sensor.

FIG. 13-15 shows magnified bottom views of variations of microneedlepatches.

FIGS. 16-17 shows magnified side views of variations of a microneedlepatch.

FIG. 18 shows a magnified bottom perspective view of a microneedlepatch.

FIG. 19 shows a representative cross sectional view of the skin composedof an outer stratum corneum covering the epidermal and dermal layers ofskin and the underlying subcutaneous tissue, with a variation of amicroneedle patch attached thereto.

FIG. 20a shows a magnified side view of a variation of a microneedlepatch including multiple electrodes.

FIG. 20b -20D show variations of a microneedle patches includingmultiple electrodes.

FIG. 21 shows a schematic view of an energy emitting system including amicroneedle patch sensor placed behind a subject's knee.

FIGS. 22-23 show schematic views of energy emitting systems including anelectrode needle and sensor.

FIGS. 24-25 show schematic views of energy emitting systems including anelectrode needle without a sensor.

FIG. 26 shows a schematic view of an energy emitting system including amicroneedle patch for providing stimulation.

FIGS. 27-28 show schematic views of energy emitting systems including anelectrode needle and microneedle patch for providing stimulation.

FIG. 29a-29d show a prospective, side, top and rear views of an energyemitting device in the form of a foot cradle.

FIGS. 30A-30B show schematic views of an energy emitting device in theform of a knee support.

FIGS. 31A-31B show a schematic view of a variation of an arm applicatorand a foot, knee or leg applicator.

FIG. 32 shows a schematic view of a variation of a back applicator.

FIG. 33 shows a schematic view of a variation of a system including aback applicator, a sensor and logic controller.

FIG. 34 shows a schematic view of system including multiple backapplicators, a sensor and logic controller.

FIG. 35 shows a schematic view of a variation of a system including aback applicator held on a patient's body by an ergonomic positioningelement in the form of a belt and a logic controller.

FIG. 36 shows a schematic view of a variation of an applicator designedto stimulate a nerve responsible for phantom or neuropathic pain.

FIG. 37 shows a schematic view of a variation of a facial neuralgiaapplicator.

FIG. 38 shows a schematic view of a variation of an applicator which maybe placed over the occipital nerve for the treatment of migraines.

FIG. 39 shows a schematic view of a variation of an applicator which maybe placed over the frontal cortex for the treatment of depression.

FIG. 40 shows a schematic view of a variation an applicator in the formof a stimulatory coil platform for positioning one or more coils inproximity to a knee or popliteal nerve.

FIG. 41 shows a schematic view of a system including a variation of aback applicator held on a patient's body by an ergonomic positioningelement in the form of a shoulder harness, a sensor, and a logiccontroller.

FIGS. 42A and 42B show an example of how the amount of stimulatory powerrequired to achieve a desired stimulus may be automatically adjusted asa result of fibroses.

FIGS. 43A and 43B show variations of a coil device positioned on askull.

DETAILED DESCRIPTION

In certain variations, apparatus and methods for magnetic inductiontherapy, in which dosage of magnetic energy can be regulated accordingto conduction in a target nerve exposed to the magnetic field areprovided.

In certain variations, apparatus and methods for magnetic inductiontherapy, in which the flow of magnetic energy can be adjusteddirectionally by the patient or a healthcare provider without alteringthe position of a housing containing conductive coils that produce themagnetic field are provided.

In certain variations, apparatus and methods for treating a variety ofailments by providing energy to a target nerve, for example magneticenergy, electrical energy or ultrasound energy, at a location and in anamount optimized by detecting conduction in the target nerve areprovided.

In certain variations, an energy emitting apparatus for delivering amedical therapy that includes one or more energy generators, a logiccontroller electrically connected to the one or more energy generators,and one or more sensors for detecting electric conduction in a targetnerve, which are connected to the logic controller is provided. The oneor more energy generators produce energy focused on the target nerveupon receiving a signal from the logic controller, and the appliedenergy is varied by the logic controller according to an input providedby the one or more sensors based on electric conduction in the targetnerve. The feedback provided by the sensors to the logic controllerabout the efficacy of the applied treatment causes the logic controllerto modulate the current transmitted to the coils.

The applied energy may be a magnetic field, an electrical field, anultrasound, a visible light, or an infrared or an ultraviolet energy.When a magnetic field is applied, the energy-emitting device is anapparatus that provides a magnetic induction therapy and that includesone or more conductive coils disposed in an ergonomic housing. A logiccontroller is electrically connected to the one or more coils, and oneor more sensors detect electric conduction in the target nerve and areconnected to the logic controller so to provide a feedback to the logiccontroller. The conductive coils receive an electric current from thelogic controller and produce a magnetic field focused on a target nerve,and the electric current fed by the logic controller is varied by thelogic controller according to an input provided by the sensors, therebycausing amplitude, frequency or direction of the magnetic field, or thefiring sequence of the one or more coils, to be varied according to theefficiency of the treatment provided to the target nerve. In certainvariations, the housing containing the conductive coils may be aflexible wrap, a cradle or a garment, and the coils may be overlappingand/or be disposed in different positions within the housing, so togenerate a magnetic field on different body parts with the desireddirection and amplitude.

The one or more coils may be stationary or movable within the housing,making it possible to optimize the direction of magnetic flow to thetarget nerve by disposing the coils in the most effective direction. Indifferent variations, the coils may be movable manually by acting on aknob, lever, or similar type of actuator, or may be translatedautomatically by the logic controller in response to the input providedby the sensors. When a preferred position for the coils has beenestablished, the coils may be locked in position and maintain thatposition during successive therapy sessions. In other variations, thesensors may be incorporated within the housing, or instead may bedisposed on a body part of interest independently of the housing.

In still other variations, the inductive coils are disposed in a housingthat is situated externally to a patient's body, and additionalinductive coils are implanted into the body of the patient and aremagnetically coupled to the external inductive coils. With this coilarrangement, energy may be transmitted from the external coils to theinternal coils either to recharge or to activate an implantable device.In yet other variations, the electric current may varied by the logiccontroller both on the basis of an input provided by the one or moresensors and also an input provided by the patient according to amuscular response she has perceived, for example, the twitching of a toeafter application of the magnetic field.

In yet other variations, the source of energy for nerve stimulation maybe electrical energy and nerve conduction may be detected at a sitesufficiently distant from the site of stimulation, so to enabledetection of nerve conduction despite the confounding interference fromthe direct electrical stimuli. In these variations, direct electricalstimulation of nerve and muscle may be tailored to provide optimaltherapy and, in the case of electrode migration or other electrodemalfunction, to report lack of stimulation of the bodily tissues.Furthermore, these variations enable a reduction in power requirement,because control of the signal is provided by the sensor to the signalgenerator loop.

In other variations, an energy emitting system for providing a medicaltherapy is provided. The system may include one or more conductive coilsdisposed within or along a housing and configured to generate a magneticfield focused on a target nerve in proximity to coils; one or moresensors in the form of microneedle patch configured to detect electricalconduction in the target nerve; and a controller coupled to theconductive coils and optionally in communication with the sensor.

In other variations, an energy emitting system for providing, a medicaltherapy is provided. The system may include one or more microneedlepatches having one or more microneedle arrays deposited on a surface ofone or more electrodes and configured to generate or deliver anelectrical or magnetic stimulus or field focused on a target nerve inproximity to the microneedle patch; one or more sensors configured todetect electrical conduction in the target nerve; and a controllercoupled to the conductive coils and optionally in communication with thesensor. Optionally, the above variations may incorporate an electrodeneedle. Optionally, the above variations or systems may be utilizedwithout a sensor or mechanism for detecting conduction or stimulation.

Methods of use of the above apparatus, systems and variations thereoffor treating various conditions are also described herein.

Referring first to FIG. 1, a first variation includes a coil wrap 20,which is depicted as disposed over ankle 22 circumferentially tosurround a portion of tibial nerve 24. Because tibial nerve 24 istargeted, this variation is particularly suited for the treatment of OABand VI. In other variations, coil wrap 20 may be configured to surroundother body parts that contain a portion of tibial nerve 24 or of othernerves branching from or connected to tibial nerve 24, still makingthese variations suitable for treating OAB and VI. In still othervariations, coil wrap 20 may be configured for surrounding body partsthat contain other nerves when treatments of other ailments areintended.

Coil wrap 20 may be manufactured from a variety of materials suitablefor wearing over ankle 22. Preferably, coil wrap is produced from asoft, body-compatible material, natural or synthetic, for example,cotton, wool, polyester, rayon, Gore-Tex®, or other fibers or materialsknown to a person skilled in the art as non-irritating and preferablybreathable when tailored into a garment. Coil wrap 22 may even bemanufactured from a molded or cast synthetic material, such as aurethane gel, to add extra comfort to the patient by providing a softand drapable feel. Additionally, coil wrap 20 may be produced from asingle layer of material or from multiple material layers and mayinclude padding or other filling between the layers.

Coil wrap 20 contains one or more conductive coils 26 arranged toproduce a pulsed magnetic field that will flow across tibial nerve 24and generate a current that will flow along tibial nerve 24 and spreadalong the length of tibial nerve 24 all the way to its sacral orpudendal nerve root origins. Coils 26 may be a single coil shaped in asimple helical pattern or as a figure eight coil, a four leaf clovercoil, a Helmholtz coil, a modified Helmholtz coil, or may be shaped as acombination of the aforementioned coils patterns. Additionally, othercoil designs beyond those mentioned hereinabove might be utilized aslong as a magnetic field is developed that will encompass tibial nerve24 or any other target nerve. When a plurality of coils is utilized,such coils may be disposed on a single side of ankle 22, or may bedisposed on more than one side, for example, on opposing sides,strengthening, and directionalizing the flow of the magnetic fieldthrough tibial nerve 24 or other peripheral nerves of interest.

Coil wrap 20 is preferably configured as an ergonomic wrap, for example,as an essentially cylindrical band that can be pulled over ankle 22, oras an open band that can be wrapped around ankle 22 and have its endsconnected with a buckle, a hoop and loop system, or any other closingsystem known to a person skilled in the art. By properly adjusting theposition of coil wrap 20 over ankle 22, a patient or a health careprovider may optimize the flow of the magnetic field through tibialnerve 24, based on system feedback or on sensory perceptions of thepatient, as described in greater detail below.

The electric current that produces the magnetic field by flowing throughcoils 26 is supplied by a programmable logic controller 28, which isconnected to coils 26, for example, with a power cord 32. A sensor 30that feeds information to logic, controller 28 is also provided, inorder to tailor the strength of the magnetic field and controlactivation of coils 26 based on nerve conduction. The purpose of sensor30 is to detect and record the firing of the target nerve and to providerelated information to logic controller 28, so to render the intendedtherapy most effective. For example, sensor input may cause logiccontroller 28 to alter the strength or pulse amplitude of the magneticfield based on sensor input, or fire the coils in a certain sequence.

In this variation, as well as in the other variations describedhereinafter, sensor 30 may include one or more sensor patches and may beplaced at different distances from the region of direct exposure to themagnetic field. For example, sensor 30 may be configured as a voltage orcurrent detector in the form of an EKG patch and may be placed anywherein the vicinity of the target nerve to detect its activation. For easeof description, the term “coils” will be used hereinafter to indicate“one or more coils” and “sensor” to indicate “one or more sensors,”unless specified otherwise.

By virtue of the above described arrangement, coil wrap 20 provides areproducibly correct level of stimulation during an initial therapysession and during successive therapy sessions, because the presence orabsence of nerve conduction is detected and, in some variations,measured when coil wrap 20 is first fitted and fine-tuned on thepatient. In addition to properly modulating the applied magnetic field,the positioning of coils 26 over ankle 22 may also be tailored accordingto the input provided by sensor 30, so to fine-tune the direction of themagnetic field. Such an adjustment of the direction, amplitude, andlevel of the stimulation provided to the target nerve through the abovedescribed automated feedback loop, to ensure that peripheral nerveconduction is being achieved, is one of the key features.

If the magnetic pulse does not substantially interfere with sensor 30,sensor 30 may be placed directly within the field of stimulation, sothat power supplied to the system may be conserved. This is particularlyimportant for battery-powered systems. Alternatively, sensor 30 may alsobe placed at a distance from the magnetic field and still properlydetect neural stimulation.

In a method of use of coil wrap 20, the amplitude and/or firing sequenceof coils 26 may be ramped up progressively, so that the magnetic fieldis increased in strength and/or breadth until nerve conduction isdetected, after which the applied stimulus is adjusted or maintained atits current level for the remainder of the therapy. The level ofstimulation may be also controlled through a combination of feedbackfrom sensor 30 and feedback based on perceptions of the patient. Forexample, the patient may activate a switch once she perceives anexcessive stimulation, in particular, an excessive level of muscularstimulation. In one instance, the patient may be asked to push a buttonor turn a knob when she feels her toe twitching or when she experiencesparesthesia over the sole of her foot. The patient will then continuepressing the button or keep the knob in the rotated position until shecan no longer feel her toe twitching or paresthesia in her foot,indicating that that level of applied stimulation corresponds to anoptimal therapy level. From that point on, the patient may be instructedto simply retain her foot, knee, or other limb within coil wrap 20 untiltherapy has been terminated while the system is kept at the optimallevel. Adding patient input enables control of coil wrap 20 duringoutpatient treatments, because the patient is now able to adjust theintensity of the magnetic field herself beyond the signals provided tologic controller 28 by sensor 30.

Detecting and, if the case, measuring conduction in one or more nervesalong the conduction pathways of the stimulated nerve confirms that thetarget nerve has been stimulated, providing an accurate assessment ofthe efficiency of the applied therapy on the patient. A concomitantdetection of muscle contraction may also confirm that the target nerveis being stimulated and provide an indication to the patient or to ahealthcare provider as to whether stimulation has been applied at anexcessive level in view of the anatomical and physiologicalcharacteristics of the patient.

Based on the foregoing, coil wrap 20 allows for a consistent,user-friendly targeting and modulation of the peripheral nerves via theposterior tibial nerve on an outpatient basis, in particular, thetargeting and modulation of the pudendal nerve and of the sacral plexus.When multiple coils 26 are present, coils 26 may be activatedsimultaneously or differentially to generate the desired magnetic field.The direction and location of each of coils 26 may be reversibly orirreversibly adjusted by the healthcare provider or by the patient,customizing the location of the applied stimulation to the anatomy andtherapy needs of each patient. After a healthcare provider has optimizedposition and firing sequence for each of coils 26, the patient may besent borne with coil wrap 20 adjusted to consistently target the desirednerve. In one variant of the present variation, an automatic feedbacksystem adjusts one or more of firing sequence, firing strength orposition of coils 26 within coil wrap 20 during the initial setup andalso during successive therapy sessions.

In summary, certain variations include the creation of a loop consistingof feeding information on nerve conduction to logic controller 28 and onlogic controller 28 tailoring the electrical current sent to coil wrap20 according to the information received from sensor 26 based on whetheror not the nerve is receiving the desired stimulation and, in somevariations, the desired amount of stimulation. This arrangement offersan unparalleled level of therapy control and flexibility within a homecare setting, because a consistent, repeatable stimulation of the targetnerve can be attained. Aside from adjusting the position of coils 26 inaccordance with the patient's anatomy and physiological variations,controlling pulse amplitude is also of great importance even duringdifferent therapy sessions with the same patient. For example, a patientwith leg edema will encounter difficulties in properly adjusting coilwrap 20 based on whether her legs and ankles are swollen or not swollen,and the power required to penetrate to posterior tibial nerve 24 (in thecase of a VI therapy) will vary greatly due to the variable depth of thenerve. Thus, having feedback provided by sensor 26 becomes a necessityfor achieving an accurate dosage of the treatment rather than an option.Benchtop testing has demonstrated that a system constructed as describedherein is capable of non-invasively generating electrical currentssimilar to those found in therapeutic electro-stimulation and to do soin different settings.

Referring now to FIG. 2, a second variation will be described withreference to a coil wrap 34 disposed over ankle 36 for the purpose oftreating VI by targeting tibial nerve 38. In this second variation, oneor more Helmholtz coils 40 are disposed within coil wrap 34 to create amore narrowly directed magnetic field over tibial nerve 38. Like in theall other variations described herein, more than one coil (in thepresent variation, more than one Helmholtz coil 40) may be placed withincoil wrap 34 and be disposed in different positions within coil wrap 34,in order to optimize magnetic flux over tibial nerve. For example, twoHelmholtz coils may be disposed one opposite to the other within coilwrap 34.

Having coil windings arranged along a common longitudinal axis, asrequired in a Helmholtz coil configuration, generates a more focusedmagnetic field and a more accurate targeting of tibial nerve 38 or ofany other nerve. Like in the previous variation, the operation of coils40 is controlled by a logic controller 42, which is in turn connected tosensor 44 that monitors conduction in tibial nerve 41 and that generatesa feedback to logic controller 42 about the efficiency of the therapy inprogress. Therefore, like in the previous variation, the coupling ofsensor 44 with logic controller 42 optimizes operation of cod wrap 34according to results measured at the level of tibial nerve 38. Also likein the previous variation, manual adjustments to the parameters ofelectric current provided by logic controller 42 to Helmholtz coil 40may also be made manually by the patient or by a healthcare provider,and coil wrap 34 may be structured so that the position of Helmholtzcoil 40 within coil wrap 34 is adjusted as desired either manually bythe patient or by a healthcare provider, or automatically by logiccontroller 42.

Referring now to FIG. 3, a third variation includes a coil wrap 46configured for wrapping over the popliteal fossa of a patient, in theregion of the knee, to stimulate the posterior tibial nerve (not shown).The configuration and structure of coil wrap 46 reflect the body portioncovered by coil wrap 46, but the key system components of coil wrap 46,such as the type, number and disposition of the coils (for example, theuse of overlapping coils); the connections of the coils with a logiccontroller; and the use of one or more sensors (also not shown) todetect nerve conduction are all comparable to those in the previouslydescribed variations.

Referring now to FIG. 4, a fourth variation includes a footrest or footcradle 48, which is structured to contain at least a portion of a foot50. One or more coils 52 are enclosed within cradle 48, and a sensor 54is disposed along the pathway of tibial nerve 55, sensing conduction intibial nerve 55, and is also connected to a logic controller 56. Coils52, sensor 54 and logic controller 56 may be arranged in differentconfigurations, in the same manner as in the preceding variations.

Cradle 48 may be made from a variety of materials and may be monolithic,or have a hollow or semi-hollow structure to enable the movement ofcoils 52 within cradle 48, as described in greater detail below.Preferably, cradle 48 has an ergonomically design allowing the ankle andheel of the patient to be retained within cradle 48, in a position thatmatches the positions of stimulating coils 52 to the area ofstimulation. The design of cradle 48 provides for a particularlycomfortable delivery of therapy to patients that prefer to remain seatedduring their therapy, and enables the patient to perform the requiredtherapy within a health care facility, or to take cradle 48 home,typically after an initial session and appropriate training in a healthcare facility. In that event, the patient will be trained to applysensor 54 autonomously and to adjust stimulation to a comfortable level.

FIG. 4 shows coils 52 disposed as overlapping and the use of a singlesensor patch 54 positioned proximally to the stimulation site. However,coil 52 may be configured as a single coil, a figure eight coil, a fourleaf clover coil, a Helmholtz coil, a modified Helmholtz coil or a anycombination of the aforementioned coils, or as any other coil designproviding an effective stimulation to the target nerve. In addition,coils 52 may be fired sequentially or simultaneously according to thefeedback provided by sensor 54.

In one variant of this variation, sensor 54 may include a conductiveelectrode patch that provides a feedback to logic controller 56 foradjusting, if necessary, the stimulation parameters of coils 52.Alternatively, sensor 54 may be a sensor patch that is either applied tothe skin of the patient or is incorporated within the structure ofcradle 48.

Referring now to FIG. 5, a fifth variation includes a knee rest or kneecradle 58 that contains one or more conductive coils 60, one or moresensors 62 and a logic controller 64. The components of this variationare similar to those described with reference to the precedingvariations, as regards the structure and materials of cradle 58, thenature and disposition of coils 60, the type and operation of sensor 62,and the function and operation of logic controller 64. Cradle 58 isconfigured to target the popliteal fossa of the patient, thus to targettibial nerve 66. In that respect, the present variation is similar tothe variation illustrated in FIG. 3, but while the variation of FIG. 3is configured as a wrap that may be worn while the patient is standing,the present variation is configured as a cradle that is more suited fortreatment while the patient is sitting or laying down.

A method of use of the foot cradle depicted in FIG. 4 is described withreference to FIGS. 6A-6D. During a first step illustrated in FIG. 6A,foot 68 is disposed in cradle 70 that contains one or more conductivecoils 72, which are connected to a logic controller (not shown) thatmanages the flow of electric power to coils 72.

During a second step illustrated in FIG. 6B, a sensor 74 is disposed onfoot 68 or on ankle 76 or on another appropriate portion of thepatient's body, in order to detect conductivity in tibial nerve 78 or inanother target nerve.

During a third step illustrated in FIG. 6C, a healthcare provideranalyzes conductivity measurements provided by sensor 74 (for example,by reading gauge 77) and first adjusts the positioning of coils 72 untilconduction in nerve 78 is detected. For example, the healthcare providermay rotate a knob 80, slide a lever or actuate any other displacementsystem for coils 72 that is known in the art, so that coils 72 aretranslated until a magnetic field of the proper amplitude and intensityis applied to cause conduction in nerve 78. The position of coils 72 isthen fine-tuned manually until an optimal level of conduction in nerve78 is attained, and the therapy is continued for a length of time asprescribed by the attending healthcare provider.

During, a fourth, optional step illustrated in FIG. 6D, settings forsuccessive therapy sessions are set, for example by locking knob 80 (inone variation, with a pin 81) so that the healthcare provider or thepatient repeat the therapy using the predetermined settings.Alternatively, the patient may be trained to adjust the amplitude and/orstrength of the applied magnetic field, as each therapy sessionrequires.

While the present method has been described with regard to foot cradle70, the same method steps may be envisioned for coil wraps or cradles ofdifferent configurations, for example, for the coil wraps and cradlesdescribed with reference to the previous figures.

In an alternative variation, the logic controller (not shown) mayautomatically adjust coil positioning to optimize therapy during theinitial and successive sessions. While this set-up may be more difficultto implement, it also provides for an accurate targeting of the targetnerve during each therapy session, regardless of alterations in patientpositioning or changes to the anatomy of the patient (for example, whena foot is swollen). In this variation, the device simply varies theorientation of coils 84 until stimulation has been sensed.

Further, coils 84 may be translated along a single direction (forexample, horizontally) or along, a plurality of directions, to providefor the most accurate positioning of coils 84 with respect to the targetnerve.

A second method of use of the foot cradle depicted in FIG. 4 isdescribed now with reference to FIG. 7. While this second method is alsodescribed with reference to a foot cradle 82 employing one or more coils84 that have a reversibly lockable, adjustable orientation, the presentmethod may be equally implemented with a body-worn coil wrap, such asthose described with reference to the previous figures, or to othervariations. In this method, the patient or the healthcare provideradjusts the positioning of coils 84 to detect conductivity in targetnerve 89.

The position of coils 84 may be translated in different directions (inthe illustrated variation, may be translated horizontally) and may belocked in an initial position once conduction in nerve 89 is detected bya sensor (for example, sensing patch 86).

More particularly, FIG. 7A illustrates the initial positioning of foot88 into cradle 82 and of sensor patch 86 on ankle 90 or otherappropriate body part of the patient. After proper positioning of foot88 is attained, a knob 92 (or other equivalent device) may be employedto adjust the position of coils 84, based on the signals (for example,nerve conduction signals) provided by sensor patch 86, as shown in FIG.7B.

With reference to FIG. 7C, after neural conduction is detected, coils 84are locked in place, and, with further reference to FIG. 7D, foot cradle82 retains coils 84 locked in position for further use in a home orhealthcare office environment. Therefore, in the present method, thepatient or a healthcare provider simply adjusts coil position by slidingcoils 84 back and along one axis until electric conduction in the targetnerve is detected, although adjustments along all three axes may bepossible in different variants of the present variation.

Referring now to FIG. 8, a sixth variation relates to the use ofmultiple sensors. While FIG. 8 depicts a variation shaped as a footcradle 98, it should be understood that the following description alsorelates to any other design, whether shaped as a cradle or a wrap orotherwise. The plurality of sensors 94 described herein may detect avariety of physiologic changes, including neural impulses, muscularcontraction, twitching, etc. that may occur with neural or muscularstimulation.

One or more of the illustrated sensors 94 may be employed over bodyregions being stimulated (for example, back, leg, arm, neck, head,torso, etc.) and may be either incorporated within an actual cradle orwrap or, otherwise, be applied separately from the cradle or the wrap.

Sensors 94 may be structured as disposable, single-use, EKG-type patchesthat are attached to the body outside of cradle 98 along the nerveconduction pathway and are then connected to the logic controller (notshown) before beginning therapy. This arrangement provides for anintimate body contact of sensors 94 without the risk of infection orother detrimental side effects that may be present with transcutaneousdevices. Sensors 94 may be employed, both for beginning and formonitoring the stimulation therapy; more specifically, sensors 94 may beemployed during, the beginning of the therapy to optimize the strengthof the magnetic field and/or to adjust the positioning of coils 96within the cradle 98. Once therapy has begun, sensors 94 continue tomonitor nerve conduction to ensure that the correct level of stimulationis being provided. In the event that for some reason nerve conductiondecays during therapy, the logic controller can automatically adjust themagnetic field, ensuring that the appropriate therapy is delivered forthe appropriate amount of time.

One or more of sensors 94 in this variation, or any of the variationsdescribed herein, may take the form of an inductive coil designed toreceive impulses from the underlying nerves, so that inductivetechnologies may be used to both stimulate the nerve or tissues as well,as to record the effect of the stimulation on nerves or tissues. Any ofsensors 94 may be connected to the logic, controller through one or moreconnection modes, including, but not limited to, wireless signals, wiredsignals, radio frequencies, Bluetooth, infrared, ultrasound, directswitching of the current circuit, etc., so long as communication betweenthe sensor and the device is effective.

During implementation of the present method, a healthcare provider maysimply elect to use sensors 94 to adjust the device, for example, tolock coils 96 into position, during the first therapy session and notrequire the use of sensors 94 during each successive therapy session.

Referring now to FIGS. 9A-9D, there are shown different, non-limitingvariations shaped as body worn ergonomic applicator garments. Each ofthese variations is shown with overlapping coils, although coils of anyconfigurations may be used. Each of the wraps of FIGS. 9A-9D correspondsto a coil wrap, into which a body part may be placed. These garmentscontain one or more sensors (not shown) that provide feedback to a logiccontroller (also not shown), or sensors may be applied separately fromthose garments. Systems may also be included for reversibly orirreversibly locking the coils within the applicator.

More particularly, FIG. 9A illustrates a variation, in which coils 100are embedded in a knee wrap 102 and are connected to a logic controllernot shown) by a connector 104. FIG. 9B instead illustrates a variation,in which coils 106 are disposed within an abdominal garment, for exampleshorts 108 and in which coils 106 are also connected to a logiccontroller (not shown) by a connector 110. A marking 112 may be added onone side of shorts 108 to indicate wrap orientation. FIG. 9C illustratesa coil wrap shaped like a band 114, in which coils 116 are connected toa logic controller (not shown) by a connector 118. When this variationis employed, band 114 may be wrapped around a body portion (for example,an arm) and be retained in place by a system known in the art, forexample, a hook and loop system, a strap and buckle system, or simply ahook disposed at one end of band 114 for engaging fabric or othermaterial in another portion of band 114. FIG. 9D illustrates a variationshaped as a shoulder strap 120, the length of which may be adjusted by abuckle 122 and which has coils 124 disposed in one or more points, forexample, at the joint between an arm and a shoulder as shown. Each ofthese variations includes one or ore sensors (not shown) that may becoupled to the garment, or that may be applied separately from thegarment.

Other variations that are not illustrated include, bur are not limitedto: a head worn garment, such as a cap; a neck worn garment, such as aneck brace; and a lower-back garment. Each garment and applicator mayalso utilize the locking, targeting coil feature described previously,without requiring the use of the any sensing components after a properpositioning of the coils in relation to the target nerve or nerves hasbeen established.

Still other variations are depicted in FIGS. 10 and 11. In thesevariations, the source of energy for nerve stimulation is electricalenergy that is dispensed through a percutaneous stimulator, such as apercutaneous needle 124, or a transcutaneous stimulator, such as anelectrode 126. As shown in FIG. 10, an electrical pulse controller 128is electrically connected both to percutaneous needle 124 and to sensor134, to provide the desired feedback and modulate the power topercutaneous needle 134. In the variation of FIG. 11, electrical pukecontroller 130 is connected both to electrode 126 and to sensor 136, andperforms a function similar to that of electrical pulse controller 128.With these variations, nerve conduction may be detected at a sitesufficiently distant from the site of stimulation, so to enabledetection of nerve conduction despite the confounding interference fromthe direct electrical stimuli. Further, direct electrical stimulation ofnerve and muscle may be tailored to provide optimal therapy and, in thecase of electrode migration or other electrode malfunction, to reportlack of stimulation of the bodily tissues. Still further, thesevariations enable a reduction in power requirement, because control ofthe signal is provided by the sensor to the signal generator loop.

As shown, a device constructed according to the principles describedherein provides a targeted and precise stimulation of the posteriortibial nerve, or of other peripheral nerves, in a non-invasive manner byemploying an ergonomic wrap or cradle that specifically targets theposterior tibial nerve in a consistent and repeatable manner. Forexample, in patients with OAB or VI, the novel, reversibly lockablemovement of the coils and the use of a logic controller-sensor loopenables the application of a magnetic field that can be varied inlocation, amplitude and strength according to the amount of stimulationactually induced in one or more target nerves and of the response of thepatient to the therapy. An apparatus according to the variationsdescribed, herein may deliver any frequency of stimulation, includinglow frequencies, high frequencies, mid frequencies and ultrahighfrequencies, and overlapping and non-overlapping coils may be used togenerate the desired field, although overlapping or Helmholtz coils arepreferred due to their ability to target a broader region and achievemore thorough stimulation.

Ailments that may be treated through the use of apparatus and methods asdescribed herein include not only OAB and VI, but also obesity,depression, urinary incontinence, fecal incontinence, hypertension,pain, back pain, restless leg syndrome, Guillain Barre syndrome,quadriplegia, paraplegia, diabetic polyneuropthy, dyskinesias,paresthesias, dental procedure pain, knee osteoarthritis, anesthesia(pain relief during surgery), Alzheimer's disease, angina (chest painfrom heart disease), ankylosing spondylitis, back pain, burn pain,cancer pain, chronic pain, dysmenorrhea (painful menstruation),headache, hemiplegia, hemiparesis (paralysis on one side of the body),labor pain, local anesthesia during gallstone lithotripsy, facial pain,trigeminal neuralgia, bruxism (tooth grinding) pain, myofascial pain,pregnancy-related nausea or vomiting, neck and shoulder pain, pain frombroken bones, rib fracture or acute trauma, diabetic peripheralneuropathy, phantom limb pain, post-herpetic neuralgia (pain aftershingles), postoperative ileus (bowel obstruction), irritable bowelsyndrome, postoperative nausea or vomiting, postoperative pain,post-stroke rehabilitation, rheumatoid arthritis, skin ulcers, spinalcord injury, temporomandibular joint pain, detrusor instability, spinalmuscular atrophy (in children), pain during hysteroscopy, gastroparesis,chronic obstructive pulmonary disease rehabilitation, carpal tunnelsyndrome, soft tissue injury, multiple sclerosis, intermittentclaudication, attention-deficit hyperactivity disorder (ADHD), cognitiveimpairment, knee replacement pain, achalasia, atopic eczema, bursitis,carpal tunnel syndrome, dementia, depression, dry mouth, dystonia,enhanced blood flow in the brain, enhanced blood perfusion of the uterusand placenta, esophageal spasm, fibromyalgia, fracture pain,Guillain-Barre syndrome, hemophilia, herpes, hip pain, interstitialcystitis, irritable bowel syndrome, pruritis, joint pain, laborinduction, local anesthesia, menstrual cramps, muscle cramps, musclespasticity, muscle strain or pain, musculoskeletal trauma, myofascialpain dysfunction syndrome, nerve damage, osteoarthritis, pain medicationadjunct, pancreatitis, Raynaud's phenomenon, repetitive strain injuries,sacral pain, schizophrenia, shingles, shoulder subluxation, sickle cellanemia pain, Skin flap ischemia (during plastic surgery), sphincter ofOddi disorders, sports injuries, thrombophlebitis, tinnitus (ringing inthe ear), restless legs, tremor, whiplash and neuralgias. In contrast toimplantable nerve stimulators, this therapy is completely noninvasiveand does not require a major surgery to implant a permanent nervestimulation device. Moreover, this therapy can be controlled to optimizethe level of therapy delivered according to power consumption and nervestimulation requirements and need not be delivered by a professionalhealthcare provider.

In other variations, neural stimulation may be applied as electricaltranscutaneous stimulation, for example, by inserting an invasiveelectrical needle into a target body part and by modulating stimulationis modulated on the basis of information sent back to the logiccontroller from the one or more sensors that are used to detect and/ormaintain the correct level of stimulation. The transcutaneous electricalstimulation sensor may be placed in the body independently or beincorporated within the wrap and may provide, among other things,feedback as to the quality of the electrical connection to the skin,which is directly related to the burn risk inherently associated withthis type of therapy. In fact, these methods of stimulation may not beoptimal due to the resulting skin irritation and risk of potentialburns, a very serious issue in the large percentage of patients thathave neuropathies. Even when patches are applied to monitortranscutaneous stimulation very closely, the patches may still becomedisplaced and allow a burn to occur. Moreover, potentially interferingelectrical impulses may develop at the treatment site, creating a noisyenvironment for the detection of nerve conduction.

In still other variations, an external coil or coils may be inductivelyconnected to an implanted coil or coils may be utilized, in thesevariations, an ergonomic applicator may be adjusted by the user or by ahealthcare provider such to optimize inductive power transmissionbetween the external and implanted coils. One or more sensors may beutilized to provide a feedback that the relative coil positions havebeen optimized, and the external coil may then be reversibly locked intoposition within the ergonomic applicator. Two applications of thisvariation relate to the transfer of power to recharge an implantabledevice, and to the transfer of power to activate an implantable device.

In the first application, when an implantable rechargeable device isutilized, the external coils may be used for recharging the implanteddevice by means of inductive fields generated by the external coils. Theexternal coils may include circuitry that determines the amount ofresistance encountered by the magnetic field or other electricalproperties related to the quality and degree of the magnetic couplingthat is being established. Based on this feedback, the position of theexternal coils may be adjusted manually or automatically to optimize thecoupling achieved with during each recharging session. Alternatively, asensor may be incorporated into the implantable device and maycommunicate the degree and quality of the magnetic coupling to theexternal coils and/or the connected circuitry via wirelesscommunication, providing a feedback for the automatic or manualadjustment of the external recharging coils.

The coils within the ergonomic applicator may be reversibly locked intoplace for the duration of the recharge session, and the implantabledevice may also communicate to the external recharging unit that theimplantable device has been fully recharged, terminating the rechargingsession has been completed. By providing for an intermittent rechargingof an implanted device, an apparatus according as described hereinenables the implantable device to devote more power to performing itsintended function optimally and with a lesser concern about protectingor extending battery life.

In the second application, the powering coils may contain circuitry todetermine the amount of resistance encountered by the applied magneticfield, or other electrical properties that may reflect the quality anddegree of the magnetic coupling that is being achieved. Based on thisfeedback, the powering coils in the applicator may be adjusted manuallyor automatically to activate and optimize the coil coupling at thebeginning of each therapy session. Alternatively, a sensor may beincorporated into the implantable device and communicate the degree andquality of the magnetic coupling externally via wireless communication,which may in turn provide feedback for the automatic or manualadjustment of the powering coil. In one variant of the presentvariation, the inductive coils may be magnetically coupled to a needletargeting the posterior tibial nerve.

An exemplary method of use of an apparatus as described herein on apatient suffering from VI and/or OAB includes the following steps:

The patient places a conductive wrap contained within a flexiblematerial over a region of the ankle (or alternatively over the knee) toprovide the required pulsed magnetic field. Alternatively, the patientmay use an ergonomic foot/leg rest or cradle having embedded coils.

A sensor (for example, a sensor patch) is placed on the patient's bodyalong the path of the nerve, ideally proximal to the stimulation site toensure afferent nerve stimulation, and is connected to a logiccontroller.

A physician or healthcare provider adjusts the coils in the wrap orcradle until nerve conduction is achieved based on patient and sensorfeedback. An optimal position is sought, and the coils may be reversiblylocked into position within the conductive wrap or ergonomic, cradle andremain in this position during subsequent use.

During the therapy session, the logic controller provides an electriccurrent to the coils, generating an inductive magnetic field. In onevariation, this field begins at low amplitude and slowly ramps up untilnerve conduction exceeds a threshold level, as signaled by the sensorand possibly by the patient, who may feel motory conduction.Alternatively, one or more coils may also be activated to increase thecovered area of stimulation in the event that stimulation does not occurwith the initial coil configuration or is inadequate

The optimal stimulation may be determined in a variety of manners, forexample, by measuring, exposure to electromagnetic fields capable ofgenerating a square wave electric signal at a frequency of 10-30 Hz atthe targeted tissue depth. The square wave configuration of the signalmay be generated via Fourier transformation or may be a ramped currentgenerated in any manner.

The inductive magnetic pulses continue for an appropriate duration ofuse, for example, for 15-30 minutes. The sensor may remain in placeduring the entire therapy session to ensure that stimulation occursconsistently and to provide for appropriate corrections if nerveconduction deteriorated. The logic controller may be powered either by aportable power source such as a battery, or by or a fixed power sourcesuch as a traditional wall outlet.

The conductive wrap and/or ergonomic cradle is removed from the bodywhen therapeutic stimulation is not being delivered, typically at theend of the therapy session.

The conductive wrap and/or ergonomic cradle is reapplied along with thesensor patch (ideally disposable) from time to time as indicated, forexample, on a daily basis, and steps 4-8 are repeated.

The devices and methods described herein may be applied to any bodytissues, including nerve, muscle, skin, vasculature, or any other organor tissue within the human body. Further, the devices and methodsdescribed herein may be used to treat any conditions suited forneuromodulation regardless of whether the stimulation source is anelectromagnetic field, a direct electric current, a RF field, infrared,energy, visible light, ultraviolet light, ultrasound, or other energydispensing device.

In other variations, as shown in FIG. 12, an energy emitting system 210for providing, a medical therapy includes one or more conductive coils212 disposed within or along a housing 214, one or more sensors 216configured to detect electrical conduction in a target nerve or todetect muscle stimulation, and a controller 218 connected or coupled tothe conductive coils 212 and optionally in communication with the sensor216. In certain variations (as shown in FIG. 12), the controller 218 canbe integral with the housing 214). The coils 212 are configured suchthat an electrical current generated by the controller 218 is passedthrough the coils 212 generating a magnetic field which will stimulate atarget nerve, e.g., the tibial nerve 220, a muscle or other body partcontaining a portion of a target nerve, or any nerves branching off of atarget nerve, located in proximity to the coils 212. In this particularvariation, the housing 214 is in the form of a foot cradle, as shown inFIG. 4, however, the housing could also be in the form of a flexiblewrap, garment or other design suitable for use with a subject. Invarious variations described herein, sensors may detect voltage orcurrent and may be connected, coupled, wirelessly connected or coupledor otherwise in communication with the housing and/or controller using avariety of methods or techniques known in the art. The sensor may beplaced over a muscle to detect muscle stimulation resulting fromstimulating the target nerve (as shown in FIG. 12) or over any otherportion of the subject's body suitable for detecting conduction of thetarget nerve.

Referring to FIGS. 13 and 16, the sensor may be in the form of amicroneedle patch 228, which can be removably attached to the skinsurface of a subject. The microneedle patch 228 may include a housing231, having one or more electrodes 232 and one or more microneedles 235deposited or arrayed on a surface of the electrode 232, forming one ormore microneedle arrays 234. In FIG. 13, microneedle patch 228 has theshape of a square, and the microneedles 235 are arrayed on the bottomsurface 236 of the electrode 232 in a 16×16 configuration. However, asshown in FIGS. 14-15, microneedle patches may be designed in a varietyof shapes, e.g., round, oval 229, rectangular 230, hexagonal, and avariety of sizes. The microneedles may be arrayed in a variety ofarrangements and patterns (e.g., 14×14, 12×12, etc.) depending on theparticular use and needles.

Additionally, microneedles may be attached, deposited, or arrayed on anelectrode surface or patch in a variety of configurations andarrangements, depending on where the particular microneedle patch willbe utilized and the treatment to be delivered. The number ofmicroneedles included in an array can vary. For example, the number ofmicroneedles may range from about 5 to 500 or 100 to 400 or about 200 to300 or about 256. In certain variations where microneedles are composedof strong, highly conductive material, the number of microneedlesnecessary may be less and may range from about 5 to 100 or 10 to 50 or 5to 50. However, where microneedles are composed of higher resistancemetal, a greater number of needles may be needed, e.g., about 100 to 500or about 200 to 300 or greater than 500.

Referring to FIG. 18, a magnified view of a microneedle array 234composed of one or more microneedles 235 is shown. Microneedles 235 mayinclude a base portion 238 and an upper portion 239. Microneedles 235may have lengths in the range of about 1 to 400 microns or 10 to 400microns or preferably about 100 to 150 microns, and a diameter in therange of about 1 to 100 microns. A microneedle 235 may be tapered indiameter, going from a larger to smaller diameter from the base portion238 to the upper portion 239 where the distal tip 240 of the microneedleis preferably pointed or sharp. The upper portion 239 of the microneedle235 may have a diameter in the range of about 10-30 microns or about 15to 25 microns. Optionally, for ease of production, the base portion 238of the microneedle 235 may be thicker than the distal tip 240 or upperportion 239 of the microneedle 235. In certain variations, as shown inFIG. 17, a bulb 237 may be provided at the distal tip 240 of amicroneedle 235 to provide for effective anchoring of the microneedle235 in the skin of a patient or subject. Microneedles 335 can includeany number of friction or grip increasing features. For example, theymay include projections, barbs, bulbs or a roughened surface or tip.Microneedles 235 may take on various configurations, e.g., straight,bent, filtered, hollow or a combination of the above.

In other variations, microneedles may have lengths that range from about480 to 1450 microns, widths from about 160 to 470 microns, thicknessesfrom about 30 to 100 microns and tip angles from about 20 to 90 degrees,and arrays can contain from 5 to 50 microneedles. For example,microneedles having these dimensions have been shown to be less painfulthan hypodermic needles. Length and number of microneedles can affectthe level of pain experienced. Decreasing microneedle length and/or thenumber of microneedles may be beneficial and act to further reduce painand provide comfort.

In certain variations, the one or more microneedles may include anelectrically conductive material such that the microneedles may transmitan electrical signal to an overlying electrode or other surface.Microneedles may be constructed of an electrically conductive materialand/or coated with an electrically conductive material. Optionally,microneedles may be coated with an electrically conductive material andconstructed of a non-conductive material. Microneedles may be fabricatedusing a variety of materials, e.g., metals, stainless steel, solid orcoat of gold over NI. Pd or Pd—Co. Pt, silicon, silicon dioxide,polymers, glass, biocompatible polymers, titanium, silver, or suturematerials. Biodegradable polymers may also be used such that if a tip ofa microneedle were to snap or break off during insertion, it wouldeasily biodegrade.

A microneedle array 234 may be constructed or fabricated using anyvariety of manufacturing methods known to persons of ordinary skill inthe art. Microneedles may be arrayed, attached, etched or deposited ontoa surface of an electrode. In another variation, microneedles may beetched from or deposited onto a silicon electrode, such that themicroneedle patch, including electrode and microneedles, are made fromone material creating a durable and stable microneedle patch.

As shown in FIG. 18, microneedles may be fabricated by creating micronsized holes on a silicon substrate and by using a KOH solution to createthe needle shape. In other variations, the microneedles may be made ofnon-conductive material but may still be utilized to provide superioranchoring properties such that a microneedle patch may effectivelyadhere or attach to a subject's skin.

In certain variations, microneedle arrays are fabricated by patterningSU-8 onto glass substrates and defining needle shapes by lithography.The tips of the needles can be sharpened using reactive ion etching.Optionally, holes may be drilled, e.g., by laser, through themicroneedles and base substrate. Holes may be drilled off-center, butparallel to the microneedle axis, terminating in side-opening holesalong the needle shaft below the needle tip. If desired, the holes canserve as micro fluidic needle bores for injection or infusion of drugs,medicines, insulin, proteins, nanoparticles that would encapsulate adrug or demonstrate the ability to deliver a virus for vaccinations,etc. to be used separately or in combination with electrical or magnetictherapy. The microneedles may also be coated with nickel byelectroplating, which can increase their mechanical strength.

In certain variations, microneedle patches or microneedle electrodearrays are made by fabricating master structures from which replicatesare molded and then made electrically active. For example, SU-8 may bespun on a glass substrate bearing an array mask pattern, baked, and thenexposed from the backside to from a tapered needle structure.Microneedles may be sharpened by RIE etching. A PDMS(polydimethylsiloxane) or similar material mold can then be copied fromthe master. A PMMA (polymethylmethacrylate) microneedle array is formedby solvent-casting and then released from the mold.

To provide the arrays with electrical functionality, a Ti/Cu seed layermay be deposited on the PMMA array and patterned by excimer laser toelectrically isolate adjacent rows. A Ni layer (e.g., about 15 to 30microns or 20 to 25 microns thick) may be electroplated on the patternedseed layer to enhance structural rigidity. A backside electricalconnection to the array may be formed by backside etching of a hole andforming an electrical connection through the hole.

In another variation, the microneedle array is arranged in a 16×16 array(i.e., 256 needles). Each needle has a height of about 400 microns andthe base diameter is about 100 microns. The pitch between microneedlescan be about 250 microns. The microneedle arrays are then coated withmetal and laser-etched to provide electrical functionality. Optionally,rows of microneedles can be electrically isolated from each other sothat alternating rows can provide alternating electrical polarity. Thearrays are also interfaced with a power source. Microneedles may be madeof polymer, coated with a metal, and etched to act as alternatingelectrodes. In certain variations, the firing sequence of themicroneedles by rows or groups may be varied or con figured toalternate.

In certain variations, a microneedle array may include one or moremicroneedles having multiple channels. For example, a multichannelsilicon microneedle may be constructed to deliver bioactive compoundsinto neural or other tissue while simultaneously monitoring andstimulating neurons and nerves.

FIG. 19 shows a cross sectional view of the skin 10 composed of an outerstratum corneum 15 covering the epidermis 16. The skin also includes thedermis 18, subcutaneous tissue/fat 12, and these layers cover muscletissue 14. As shown in FIG. 19, when a microneedle patch 228 is attachedto a subject's skin, the microneedles 235 pierce the outer insulatingstratum corneum layer 15. The microneedle patch 228 can detect currentpassing, through a stimulated nerve, and provide a superior signal asthe current detected is conducted through the microneedles 235, therebybypassing the poorly conductive stratum corneum layer 15 which generallyencompasses the outer 10 to 15 microns of skin. In other variations,microneedles 215 may be fabricated to be long enough to penetrate thestratum corneum 15, but short enough not to puncture nerve endings, thusreducing the risk of pain, infection or injury.

In certain variations, microneedles are formed such that they are indirect contact with their corresponding, or overlying electrodes. Forexample, a microneedle patch may include an adhesive electrode pad andmay utilize a conductive gel to help hold the microneedles in place toprevent shear forces from breaking or bending the microneedles.

In certain variation, as shown in FIGS. 20a-20d a microneedle patch orapplicator may include multiple electrodes on a single patch orapplicator, e.g., positive, negative, and/or control or groundelectrodes, where the microneedles will be grouped in multiple arrayssuch that they conduct to the appropriate electrode. For example, FIGS.20a and 20b show a single patch having positive, negative and controlelectrodes where a separate array of electrodes is in contact with eachrespective electrode. This arrangement can be created using a singlepatch. Alternatively, as shown in FIG. 20c , two patches may beimplemented, one including the control electrode with correspondingmicroneedle array and the other including the positive and negativeelectrodes with corresponding microneedle arrays. The various electrodescould be interchanged. Alternatively, as shown in FIG. 20d , threepatches may be implemented, each having a separate electrode (control,positive, or negative) with a corresponding microneedle array. In use incertain variations, the control may be attached above or near bone,while the positive and/or negative electrodes may be attached abovenerve or muscle.

Referring again to FIG. 12, the energy emitting system 210 can be usedto treat or prevent various conditions, e.g., urinary incontinence,restless leg syndrome and fecal incontinence, among others. Energyemitting system 210 includes one or more conductive coils 212 disposedwithin or along a housing 214, one or more sensors 216 configured todetect electrical conduction in the target nerve or to detect musclestimulation, and a controller 218 coupled to the conductive coils 212and optionally in communication with the sensor 216. The coils 212 areconfigured such that an electrical current generated by the controller218 is passed through the coils 212 generating a magnetic field whichwill stimulate a target nerve, e.g., the tibial nerve 220, a muscle orother body part containing a portion of a target nerve, or any nervesbranching off of a target nerve, located in proximity to the coils 212.In this particular variation, the housing 214 is in the form of a footcradle, as shown in FIG. 4, however, the housing could also be in theform of a flexible wrap, garment or other design suitable for use with asubject.

Referring again to FIG. 12, energy emitting system 210 may be used totreat or prevent various conditions, e.g., urinary incontinence,restless leg syndrome or fecal incontinence. In certain variations, amethod of using the energy emitting system 210 includes positioning afirst portion of a patient's body, for example a foot, ankle, or leg,relative to housing 214 such that a posterior tibial nerve 220 withinthe first portion of the patient's body is in proximity to one or moreconductive coils 212 disposed within or along the housing. In thisparticular variation, a patient's foot is positioned in a housing whichis in the form of a foot cradle 215. A sensor in the form of amicroneedle patch 228 may optionally be positioned along a secondportion of the patient's body in proximity to the posterior tibial nerve220. In this particular variation, microneedle patch 228 is attached tothe patient's foot over a muscle to detect muscle stimulation.Alternatively, a patch could be placed elsewhere on the patient, forexample, on the leg in proximity to the posterior tibial nerve 220,proximal to and up-stream from coils 212. Microneedle patch 228 may becomposed of one or more microneedle arrays and one or more electrodes,as described supra.

Once the patient's foot is in position and the microneedle patch 228(e.g., conductive microneedle patch) is in place, a current is passedfrom controller 218 through coils 212, and as a result, the coils 212generate a magnetic field which is focused on the posterior tibial nerve220. The magnetic field stimulates tibial nerve 220, generating acurrent that will flow along the tibial nerve 220 and spread along itslength, to its sacral or pudendal nerve roots. Microneedle patch 228detects corresponding muscle stimulation or twitching or electricalconduction through the stimulated posterior tibial nerve. Upondetection, the microneedle array may conduct and transmit an electricalsignal to the overlying electrode of microneedle patch 228. The signalmay be transmitted to controller 218, which can be integral or aseparate controller or device, or a separate controller coupled tocontroller 218. The controller can then be varied or adjusted (to adjustthe current or magnetic field) based on the signal received frommicroneedle patch 228 to ensure that adequate conduction of theposterior tibial nerve 220 occurs and an adequate and accurate dosage oftreatment is being received. Although shown utilizing a sensor, it isalso contemplated that the system could be used without a sensor.

Referring to FIG. 21, the method of using energy emitting system 210described above with respect to FIG. 12 may be varied such that aconductive microneedle patch 228 is placed in proximity to or proximallyover the afferent posterior tibial nerve 220, i.e., behind the patient'sknee. In this position, a conductive microneedle patch 228 detectselectrical conduction through the afferent posterior tibial nerve, i.e.,it detects the electrical signal traveling through the posterior tibialnerve back up to the brain and spinal cord or it may detectcorresponding muscle stimulation. The microneedle patch 228 sends thesignal to controller 218 or to a separate controller coupled tocontroller 218. The controller can then be varied or adjusted based onthe signal received from microneedle patch 228 to ensure that adequateconduction or stimulation of the posterior tibial nerve 220 occurs andan adequate and accurate dosage of treatment is being received.

A sensor utilized in the energy emitting system 210 may be a microneedlepatch 228 as described above or optionally the sensor may a sensor typeknown in the art (e.g. EKG sensor) or as described in any of thevariations herein. It is also contemplated that energy emitting system250 can be utilized without a sensor. Optionally, the sensor may bepositioned within or along the housing, e.g., the foot cradle, alongwith the one or more conductive coils, or positioned at a site distantfrom the housing or conductive coils.

In certain variations, energy emitting system 210 may optionally includeone or more conductive microneedle patches which can be positioned inproximity to the target nerve or muscle and provide an additional orsupplemental electrical or magnetic stimulus to the target nerve ormuscle.

Referring to FIG. 22, the energy emitting system 210 described abovewith respect to FIG. 12 may be varied to create energy emitting system260. Energy emitting system 260 further includes one or morepercutaneous electrode needles 262 or other needles or otherpercutaneous electrodes coupled to a controller 218 and having an endinsertable into a subject's body in proximity to said target nerve orstimulation site. The percutaneous electrode needle 262 is inductivelycoupled to one or more conductive coils 212. In use, a first portion ofa patient's body, for example a foot, ankle, or leg, is positionedrelative to housing 214, e.g., foot cradle 215, such that a targetnerve, e.g., posterior tibial nerve 220, located within the firstportion of the patient's body is in proximity to one or more conductivecoils 212 disposed within or along the housing 214. Conductive coils 212are positioned proximate, optionally downstream or distal to, a selectedstimulation site 261. The percutaneous electrode needle 262 is insertedthrough the skin at a location and to a depth that brings the tip inclose proximity to the stimulation site or target nerve to bestimulated. The controller 218 is activated and a current passes throughconductive coils 212. The resulting magnetic field generates a currentthat traverses the internal stimulation site 261 by passing fromconductive coils 212 to the internal percutaneous electrode needle 262,as indicated by arrow i. Also, the percutaneous electrode needle may bepositioned within the generated magnetic field, whereby the magneticfield itself generates a current in the percutaneous electrode whichstimulates a target nerve or traverses an internal stimulation site.Optionally, a current may be passed from the controller 218 throughconductive coils 212 and/or from the controller 218 through percutaneouselectrode needle 262, traversing the internal stimulation site as thecurrent passes between the cods and needle.

In energy emitting system 260, current density and subsequent electricfield intensity generated between conductive coils 212 and percutaneouselectrode needle 262 is greater than that generated by traditionalpercutaneous stimulators. A greater electric field intensity makes sitelocation for conductive coils 212 and percutaneous electrode needle 262easier. Furthermore, the load impedance through the surface of the skinis much higher than the internal impedance, and as such, the relativelyhigh load impedance lessens the likelihood of damage to tissue andnerves due to high current pulses.

Referring again to FIG. 22, a percutaneous electrode needle for use inany of the energy emitting systems described herein may include avariety of designs. For example, percutaneous electrode needle 262 mayinclude a metal or plastic handle 263 to provide a secure grip for theuser, while minimizing the risk of shock to the user. The needle tip canhave a terminal portion 264 which may extend between about 0.5 and 10 mmor about 2.0 mm from the needle tip and may be constructed out ofmedical grade stainless steel or other biocompatible metals. Thediameter of the needle can be small (less than about 0.25 mm) whichminimizes trauma during insertion. Optionally, needle 262 can be coatedwith Teflon or similar insulative material 265 except for an exposed tiparea 264. This allows for a higher field density at the tip for moreprecise operation. The exposed needle tip area 264 should have asufficiently large surface area so as not to create too high a localcurrent field that may cause irritation or pain.

In another variation, as shown in FIG. 23, percutaneous electrode needle272 may be used in energy emitting system 260. Percutaneous electrodeneedle 272 may be constructed out of medical grade stainless steel orother biocompatible electrically conductive metal. Percutaneouselectrode needle 272 includes a first end 276 for insertion into thepatient's body in proximity to the preselected internal stimulation siteor target nerve to be stimulated, and a second end 277. The size of theneedle electrode 272 is preferably small, for example 34G needleelectrode (0.22×10 mm), to minimize trauma during insertion.Percutaneous electrode needle 272 may also include an electricallyconductive adaptor, e.g., an electrically conductive tape member 273.The tape member 273 includes an electrically conductive adhesive portion274 and an electrically conductive non-adhesive portion 275.Alternatively, the adaptor may include an electrically conductive clip.The second end 277 of the needle electrode 272 preferably includes anenlarged portion to enable the electrically conductive tape member 273to be more easily adhered thereto. Once it is determined that thepercutaneous needle electrode 272 is properly positioned, the needle isfixedly adhered to the electrically conductive tape member 273 byfolding the ends of the adhesive portion 274 of the electricallyconductive tape member 272 over the second end 277 of the needleelectrode thereby forming an electrical connection there between. Thepercutaneous needle electrode 272 is electrically coupled to controller218 via electrically conductive tape member 273. Various otherimplantable or insertable electrode needles known to persons of skill inthe art may also be utilized in the above described systems.

In certain variations of energy emitting system 260 as described aboveand shown in FIGS. 22-23, a sensor 216, such as a conductive microneedlepatch 228, may be utilized to detect electrical conduction through thestimulated posterior tibial nerve 220 or to detect muscle stimulation,and transmit the signal to controller 218. The signal may be transmittedto controller 218, a separate controller or device, or a separatecontroller coupled to controller 218. The controller can then be variedor adjusted based on the signal from microneedle patch 228 to ensurethat adequate conduction of the posterior tibial nerve 220 occurs and anadequate and accurate dosage of treatment is being received. It is alsocontemplated that energy system 260 may be utilized without a sensor216, see for example FIGS. 24-25. Optionally, other types of sensors maybe used in place of a microneedle patch sensor, such as other sensorsdescribed herein and sensors known to persons of ordinary skill in theart. The sensor may be placed over a portion of the subject's bodysuitable for detecting conduction of the target nerve (e.g., on the legas shown) or over a muscle to detect muscle stimulation resulting fromstimulating the target nerve.

In certain variations, as shown in FIG. 26, an energy emitting system250 for providing a medical therapy includes a microneedle patch 252(e.g., conductive microneedle patch) having one or more microneedlearrays deposited on a surface of one or more electrodes; one or moresensors 221 configured to detect electrical conduction in the targetnerve or to detect muscle stimulation; and a controller 218 coupled tomicroneedle patch 252 and in communication with sensor 221. Themicroneedle patch 252 is configured such that an electrical currentgenerated by the controller 218 is passed through the microneedle patch252, generating a magnetic field or delivering or generating anelectrical or magnetic stimulus to a target nerve, e.g., the tibialnerve 220, a muscle or other body part containing a portion of a targetnerve, or any nerves branching of a target nerve, located in proximityto microneedle patch 252.

Referring to FIG. 26, a method of using the energy emitting system 250may include placing a conductive microneedle patch 252 on a firstportion of a patient's body, for example a foot, ankle, or leg, inproximity to posterior tibial nerve 220 within the first portion of thepatient's body. Sensor 221 is positioned along a second portion of thepatient's body in proximity to the posterior tibial nerve 220. In thisparticular variation, sensor 216 is attached to the patient's leg inproximity to the posterior tibial nerve 220, proximal to and up-streamfrom conductive microneedle patch 252. Conductive microneedle patch 252is composed of one or more microneedle arrays and one or moreelectrodes, as described in the variations above.

Once conductive microneedle patch 252 and sensor 221 are in position, acurrent is passed from controller 218 through conductive microneedlepatch 252, resulting in an electrical stimulus of the posterior tibialnerve 220. Alternatively, the microneedle array may be insulated orconstructed of non conductive material such that the microneedle patch252 generates a magnetic field that stimulates tibial nerve 220 in amanner similar to the one or more coils described in the variationsabove, without an electrical stimulus. Whether the stimulus iselectrical or magnetic, either stimulus will generate a current thatwill flow along the tibial nerve 220 and spread along its length, to itssacral or pudendal nerve roots. Sensor 221 detects electrical conductionthrough the stimulated posterior tibial nerve 220, and then transmitsthe signal to controller 218. In certain variations, the sensor may bein the form of a microneedle patch sensor. The signal may be transmittedto controller 218, a separate controller or device, or a separatecontroller coupled to controller 218. The controller can then be variedor adjusted based on the signal from sensor 221 to ensure that adequateconduction of the posterior tibial nerve 220 occurs and an adequate andaccurate dosage of treatment is being received.

The sensor utilized in the energy emitting system 250 may be a sensor ofthe type described above, with respect to other variations. Optionally,for example, the sensor may be a microneedle patch. It is alsocontemplated that energy emitting system 250 can be utilized without asensor. The sensor may be placed over a portion of the subject's bodysuitable for detecting conduction of the target nerve (e.g., on the legas shown) or over a muscle to detect muscle stimulation resulting fromstimulating the target nerve.

In certain variations, energy emitting system 250 may optionally includeone or more conductive coils disposed within or along a housing whichcan be positioned in proximity to the target nerve or muscle and providean additional or supplemental stimulation of the target nerve or muscle.

Referring to FIG. 27, the energy emitting system 250 described abovewith respect to FIG. 26 may be varied to create energy emitting system280. Energy emitting system 280 further includes one or morepercutaneous electrode needles 262 coupled to a controller 218 andhaving an end insertable into a subject's body in proximity to saidtarget nerve. Optionally, the electrode needle may be non-percutaneous,such that it is insertable in an orifice or opening in the subject, suchas a natural orifice. The percutaneous electrode needle 262 isinductively coupled to conductive microneedle patch 252. In use, amicroneedle patch 252 is placed on a first portion of a patient's body,for example a foot, ankle, or leg, in proximity to posterior tibialnerve 220 within the first portion of the patient's body and downstreamor distal to a selected stimulation site 261. The percutaneous electrodeneedle 262 is inserted through the skin at a location and to a depththat brings the tip in close proximity to the target nerve to bestimulated.

The controller 218 is activated and a current passes through microneedlepatch 252 and traverses the internal stimulation site 261 by passingfrom microneedle patch 252 to the internal percutaneous electrode needle262, as indicated by arrow i. The current passing through microneedlepatch 252 may also generate a magnetic field which can generate acurrent that traverses the internal stimulation site 261 by passing frommicroneedle patch 252 to the internal, percutaneous electrode needle262. Also, the percutaneous electrode needle may be positioned withinthe generated magnetic field, whereby the magnetic field generates acurrent in the percutaneous electrode which stimulates a target nerveand traverses an internal stimulation site. Optionally, a current may bepassed from the controller 218 through microneedle patch 252 and forfrom the controller 218 through percutaneous electrode needle 262,traversing the internal stimulation site as the current passes betweenthe patch and needle.

Referring to FIG. 28, energy emitting system 280 may be modified byusing percutaneous electrode needle 272 in place of percutaneouselectrode needle 262. Percutaneous electrode needle 272 would beconstructed and function as described above with respect to FIG. 23.Various other implantable or insertable electrode needles known topersons of skill in the art may also be utilized in the above describedsystems. Additionally, energy emitting system 280 may utilize a sensorto detect electrical conduction through the stimulated posterior tibialnerve 220 and send a corresponding signal indicative of the detectedconduction to controller 218 or other device such that the electrical ormagnetic stimulus can be adjusted as necessary. The sensor may be asensor 221, or optionally the sensor may be a microneedle patch. It isalso contemplated that energy emitting system 280 can be utilizedwithout a sensor. The sensor may be placed over a portion of thesubject's body suitable for detecting conduction of the target nerve(e.g., on the leg as shown) or over a muscle to detect musclestimulation resulting from stimulating the target nerve.

In any of the above systems, variations are contemplated where thesensors are also coupled or connected to or otherwise in communicationwith energy emitting devices, e.g., the conductive coils or conductivemicroneedle patches.

In certain variations, the one or more microneedles of the microneedlepatch may include an electrically conductive material such that themicroneedles may transmit an electrical signal to an overlying electrodeor other surface. Microneedles may be constructed of an electricallyconductive material and/or coated with an electrically conductivematerial. Optionally, microneedles may be coated with an electricallyconductive material and constructed of a non-conductive material.Microneedles may be fabricated using a variety of materials e.g.,metals, stainless steel, solid or coat of gold over NI, Pd or Pd—Co, Pt,silicon, silicon dioxide, polymers, glass, biocompatible polymers,titanium, silver, or suture materials. Biodegradable polymers may alsobe used such that if a tip of a microneedle were to snap or break offduring insertion, it would easily biodegrade. Optionally, themicroneedle patch may be non-conductive.

In certain variations, an electrode patch for improved conductance orconduction is provided. The patch can include at least one electrodehaving a first surface and/or a second surface. The electrode mayoptionally be attached to various other materials or adhesive materials.An array of microneedles may be deposited on a surface of the electrode,or attached to a patch or other material and indirectly or directlyconnected to the electrode. The array of microneedles may include aconductive material. Such patches may be used as a sensor to detectmuscle stimulation or electrical conduction, or to provide or deliver anelectrical stimulus or magnetic field, e.g., to a target nerve, and mayoptionally be used in any of the variations described herein or in anyapplication where improved conductance or conduction is desired.Microneedles yield improved reduction in impedance compared to simpleabrasion and other techniques, and are less painful and more comfortablefor the patient.

In certain variations, typical voltage sensed at the skin and detectableor conductable by a microneedle patch or microneedle array may rangefrom about 1 to 400 microvolts or about 10 to 300 microvolts.

In certain variations, methods of treating a subject with urinaryincontinence or various pelvic, floor disorders utilizing the energyemitting systems described herein are contemplated. Symptoms associatedwith urinary incontinence may be observed, detected, or diagnosed. Anenergy emitting device having one or more energy generators, e.g., oneor more conductive coils or one or more microneedle patches, may bepositioned in proximity to a target nerve, e.g., the tibial or posteriortibial nerve or popliteal or sacral nerve or branches thereof of asubject or patient along a first portion of a subject's or patient'sbody. The subject may or may not be exhibiting symptoms associated withurinary incontinence. In the case of the conductive coils, the coils maybe positioned within or along a housing, such as a foot or knee cradle,and a foot or leg may be positioned therein. In the case of amicroneedle patch, the patch may be attached to a subject's skin.Optionally, the method involves positioning a first portion of asubject's body, the subject exhibiting symptoms associated with urinaryincontinence, relative to an energy emitting device such that a targetnerve within the first portion of the body is in proximity to at leastone energy generator disposed within or along the energy emittingdevice.

A current is then passed through the energy generator to produce,generate or deliver energy, e.g., a magnetic or electromagnetic field orelectrical or magnetic energy or stimulus, focused on the tibial orposterior tibial nerve or branches thereof. This in turn may cause thestimulation of a pudendal nerve, sacral plexus, or other nerves in thepelvic floor. Various nerves innervating the various muscles,sphincters, nerves, organs and conduits of the urinary tract and bladdermay be stimulated directly or indirectly. In certain variations, acurrent is passed through one more coils, which generate a magnetic orelectromagnetic field which stimulates the posterior tibial nerve. Incertain variations, the positioning of the cods relative to the firstportion of the subject's body may be adjusted to re-focus the magneticfield on the posterior tibial nerve as needed. In certain variations, acurrent is passed through a microneedle patch generating or deliveringan electrical or magnetic stimulus or field. The positioning of themicroneedle patch relative to the first portion of the subject's bodymay be adjusted to re-focus the electrical or magnetic stimulus or fieldon the posterior tibial nerve as needed.

Optionally, electrical conduction through the target nerve, e.g., theposterior tibial nerve, or muscle stimulation can be detected via atleast one sensor. A conductive sensor may be positioned in proximity tothe posterior tibial nerve along a second portion of the subject's body.Optionally, a sensor may be positioned over a corresponding muscle todetect muscle stimulation or twitching resulting from nerve stimulation.Optionally, the electrical conduction is detected along a second portionof the subject's body which is different from the first portion of thebody. Optionally, the sensor in the form of a microneedle patch. Incertain variations, the sensor may be positioned behind a subject's kneeto detect the electrical conduction along the afferent posterior tibialnerve or on another portion of a patient's leg or foot. In othervariations, the sensor may be positioned within or along a housing alongwith the one or more conductive coils.

Where a sensor is used a signal is received from the sensors and thesignal is indicative of the electrical conduction of the target nerve,e.g., posterior tibial nerve. The current may be adjusted or variedusing a controller which is in communication with the energy generator.Adjustments may be made in response to the nerve or muscle stimulationdetected by the conductive sensor, in order to optimize or ensureadequate treatment of urinary incontinence by achieving the appropriatelevel of conductance and appropriate level of nerve or musclestimulation. Appropriate levels or parameters for current, frequency,magnetic field, treatment duration, etc., are those that result in anobserved or detected reduction or prevention of symptoms associated withurinary incontinence. Treatment could also be administered and theappropriate levels and parameters achieved through observing ordetecting reduction or prevention of symptoms where a sensor is notused. Examples of these symptoms include but are not limited to theinability to control urinary function, urinary leakage, and loss ofbladder control.

In certain variations, the amplitude, frequency, direction of agenerated magnetic field, electrical or magnetic stimulus, or firingsequence of the coils or microneedles making up the microneedle arraymay be adjusted. Optionally, the current may be varied according to amuscular response in the patient. Thus, to treat urinary incontinence,the magnetic field or electrical stimulus is applied to a subject orpatient until the desired effects (e.g., reduction of symptoms) areachieved.

In certain variations, methods of treating a subject with fecalincontinence utilizing, the energy emitting systems described herein arecontemplated. Symptoms associated with fecal incontinence may beobserved, detected or diagnosed. An energy emitting device having one ormore energy generators, e.g., one or more conductive coils or one ormore microneedle patches, may be positioned in proximity to a targetnerve, e.g., the tibial or posterior tibial nerve, or popliteal orsacral nerve or branches thereof, of a subject along a first portion ofa subject's body. The subject may or may not be exhibiting symptomsassociated with fecal incontinence. In the case of the conductive coils,the coils may be positioned within or along a housing, such as a foot orknee cradle, and a foot or leg may be positioned therein. In the case ofa microneedle patch, the patch may be attached to a subject's skin.Optionally, the method involves positioning a first portion of asubject's body, the subject exhibiting symptoms associated with fecalincontinence, relative to an energy emitting device such that a targetnerve within the first portion of the body is in proximity to at leastone energy generator disposed within or along the energy emittingdevice.

A current is then passed through the energy generator to produce,generate or deliver energy, e.g., a magnetic or electromagnetic field orelectrical or magnetic energy or stimulus, focused on the tibial orposterior tibial nerve or branches thereof. This in turn causes thestimulation of a pudendal nerve, sacral plexus, or nerves in the pelvicfloor. Various nerves innervating, the various muscles, sphincters,rectum, nerves, organs and conduits associated with bowel movements,fecal control, and the intestines may be stimulated directly orindirectly. Optionally, a current is passed through one more coils,which generate a magnetic or electromagnetic field which stimulates theposterior tibial nerve. In certain variations, the positioning of thecoils relative to the first portion of the subject's body may beadjusted to re-focus the magnetic field on the posterior tibial nerve asneeded. In certain variations, a current is passed through a microneedlepatch generating or delivering an electrical or magnetic stimulus orfield. The positioning of the microneedle patch relative to the firstportion of the subject's body may be adjusted to re-focus the electricalor magnetic stimulus or field on the posterior tibial nerve as needed.

Optionally, electrical conduction through the target nerve, e.g., theposterior tibial nerve, or muscle stimulation can be detected via atleast one sensor. A conductive sensor may be positioned in proximity tothe posterior tibial nerve along a second portion of the subject's body.Optionally, a sensor may be positioned over a corresponding muscle todetect muscle stimulation or twitching resulting, from nervestimulation. Optionally, the electrical conduction is detected along asecond portion of the subject's body which is different from the firstportion of the body. Optionally, the sensor is in the form a of amicroneedle patch. In certain variations, the sensor may be positionedbehind a subject's knee to detect the electrical conduction along theafferent posterior tibial nerve or on another portion of a patient's legor foot. In other variations, the sensor may be positioned within oralong, a housing along with the one or more conductive coils.

Where a sensor is used a signal is received from the sensors and thesignal is indicative of the electrical conduction of the target nerve,e.g., posterior tibial nerve. The current may be adjusted or variedusing a controller which is in communication with the energy generator.Adjustments may be made in response to the nerve or muscle stimulationdetected by the conductive sensor, in order to optimize or ensureadequate treatment of fecal incontinence by achieving the appropriatelevel of conductance and appropriate level of nerve or musclestimulation. Appropriate levels or parameters for current, frequency,magnetic field, treatment duration, etc., are those that result in anobserved or detected reduction or prevention of symptoms associated withfecal incontinence. Treatment could also be administered and theappropriate levels and parameters achieved through observing ordetecting reduction or prevention of symptoms where a sensor is notused. Examples of these symptoms include but are not limited: the lossof voluntary control to retain stool in the rectum; loss of fecalcontrol; inability to control bowel movements, and fecal leaking;

In certain variations, the amplitude, frequency, direction of agenerated magnetic field, electrical or magnetic stimulus, or firingsequence of the coils or microneedles making up the microneedle arraymay be adjusted. Optionally, the current may be varied according to amuscular response in the patient. Thus, to treat fecal incontinence, themagnetic field or electrical stimulus is applied to a subject or patientuntil the desired effects (e.g., reduction of symptoms) are achieved.

In certain variations, methods of treating a subject with restless legsyndrome utilizing the energy emitting systems described herein arecontemplated. Victims afflicted with Restless Leg Syndrome (RLS orEkbom's syndrome), are unable to remain seated or to stand still.Activities that require maintaining motor rest and limited cognitivestimulation, such as transportation, e.g., in a car, plane, train, etc.,or attending longer meetings, lectures, movies or other performances,become difficult if not impossible. These sensations become more severeat night and RLS patients find sleep to be virtually impossible, addingto the diminishing quality of their lives. The urge to move, whichincreases over periods of rest, can be completely dissipated bymovement, such as walking. However, once movement ceases, symptomsreturn with increased intensity. If an RLS patient is forced to liestill, symptoms will continue to build like a loaded spring and,eventually, the legs will involuntary move, relieving symptomsimmediately.

Thus, symptoms associated with restless leg syndrome may be observed,detected, or diagnosed. An energy emitting device having one or moreenergy generators, e.g., one or more conductive coils or one or moremicroneedle patches, may be positioned in proximity to a target nerve,e.g., the tibial or posterior tibial nerve, or popliteal or sacral nerveor branches thereof or other nerves associated with restless legsyndrome, of a subject along a first portion of a subject's body. Thesubject may or may not be exhibiting symptoms associated with restlessleg syndrome. In the case of the conductive coils, the coils may bepositioned within or along a housing, such as a foot or knee cradle, anda foot or leg may be positioned therein. In the case of a microneedlepatch, the patch may be attached to a subject's skin. Optionally, themethod involves positioning a first portion of a subject's body, thesubject exhibiting symptoms associated with restless leg syndrome,relative to an energy emitting device such that a target nerve withinthe first portion of the body is in proximity to at least one energygenerator disposed within or along, the energy emitting device.

A current is then passed through the energy generator to produce,generate or deliver energy, e.g., a magnetic field or electrical ormagnetic energy or stimulus, focused on the tibial or posterior tibialnerve or branches thereof or other nerves associated with restless legsyndrome. This in turn causes the stimulation of a pudendal nerve,sacral plexus or other nerves innervating the pelvic floor or variousmuscles, nerves, or organs associated with restless leg syndrome. Thevarious nerves may stimulated directly or indirectly. Optionally, acurrent is passed through one more coils, which generates a magnetic orelectromagnetic field which stimulates the posterior tibial nerve. Incertain variations, the positioning of the coils relative to the firstportion of the subject's body may be adjusted to re-focus the magneticfield on the posterior tibial nerve as needed. In certain variations, acurrent is passed through a microneedle patch generating or deliveringan electrical or magnetic stimulus or field. The positioning of themicroneedle patch relative to the first portion of the subject's bodymay be adjusted to re-focus the electrical or magnetic stimulus or fieldon the posterior tibial nerve as needed.

Optionally, electrical conduction through the target nerve, e.g., theposterior tibial nerve, or muscle stimulation can be detected via atleast one sensor. A conductive sensor may be positioned in proximity tothe posterior tibial nerve along a second portion of the subject's body.Optionally, a sensor ma be positioned over a corresponding muscle todetect muscle stimulation or twitching resulting from nerve stimulation.Optionally, the electrical conduction is detected along, a secondportion of the subject's body which is different from the first portionof the body. Optionally, the sensor in the form a of a microneedlepatch. In certain variations, the sensor may be positioned behind asubject's knee to detect the electrical conduction along the afferentposterior tibial nerve or on another portion of a patient's leg or foot.In other variations, the sensor may be positioned within or along ahousing along with the one or more conductive coils.

Where a sensor is used, a signal is received from the sensors and thesignal is indicative of the electrical conduction of the target nerve,e.g., posterior tibial nerve. The current may be adjusted or variedusing a controller which is in communication with the energy generator.Adjustments may be made in response to the nerve or muscle stimulationdetected by the conductive sensor, in order to optimize or ensureadequate treatment of restless leg syndrome by achieving the appropriatelevel of conductance and appropriate level of nerve or musclestimulation. Appropriate levels or parameters for current, frequency,magnetic field, treatment duration, etc., are those that result in anobserved or detected reduction or prevention of symptoms associated withrestless leg syndrome. Treatment could also be administered and theappropriate levels and parameters achieved through observing ordetecting reduction or prevention of symptoms where a sensor is notused. Examples of these symptoms include but are not limited to:uncomfortable sensations in the limbs, irresistible urges to move,usually the legs; motor restlessness; when at rest, symptoms return orworsen; and symptoms worsen in the evening and at night.

In certain variations, the amplitude, frequency, direction of agenerated magnetic field, electrical or magnetic stimulus, or firingsequence of the coils or microneedles making up the microneedle arraymay be adjusted. Optionally, the current may be varied according to amuscular response in the patient. Thus, to treat restless leg syndrome,the magnetic field or electrical stimulus is applied to a subject orpatient until the desired effects (e.g., reduction of symptoms) areachieved.

In certain variations, methods of treating a subject suffering frompremature ejaculation or various pelvic floor disorders utilizing theenergy emitting systems described herein are contemplated. Symptomsassociated with premature ejaculation may be observed, detected, ordiagnosed. An energy emitting device having one or more energygenerators, e.g., one or more conductive coils or one or moremicroneedle patches, may be positioned in proximity to a target nerve,e.g., the tibial or posterior tibial nerve or popliteal or sacral nerveor branches thereof of a subject along a first portion of a subject'sbody. The subject may or may not be exhibiting symptoms associated withpremature ejaculation. In the case of the conductive coils, the coilsmay be positioned within or along a housing, such as a foot or kneecradle, and a foot or leg may be positioned therein. In the case of amicroneedle patch, the patch may be attached to a subject's skin.Optionally, the method involves positioning a first portion of asubject's body, the subject exhibiting symptoms associated withpremature ejaculation, relative to an energy emitting device such that atarget nerve within the first portion of the body is in proximity to atleast one energy generator disposed within or along the energy emittingdevice.

A current is then passed through the energy generator to produce,generate or deliver energy, e.g., a magnetic or electromagnetic field orelectrical or magnetic energy or stimulus, focused on the tibial orposterior tibial nerve or branches thereof. This in turn may cause thestimulation of a pudendal nerve, sacral plexus, or other nerves in thepelvic floor or nerves associated with the control of ejaculation.Various nerves innervating the various muscles, sphincters, nerves,organs and conduits of the urinary tract, bladder or reproductivesystem, or pelvic floor may be stimulated directly or indirectly.Optionally, a current is passed through one more coils, which generatesa magnetic or electromagnetic field which stimulates the posteriortibial nerve. In certain variations, the positioning of the coilsrelative to the first portion of the subject's body may be adjusted tore-focus the magnetic field on the posterior tibial nerve as needed. Incertain variations, a current is passed through a microneedle patchgenerating or delivering an electrical or magnetic stimulus or field.The positioning of the microneedle patch relative to the first portionof the subject's body may be adjusted to re-focus the electrical ormagnetic stimulus or field on the posterior tibial nerve as needed.

Optionally, electrical conduction through the target nerve, e.g., theposterior tibial nerve, or muscle stimulation can be detected via atleast one sensor. A conductive sensor may be positioned in proximity tothe posterior tibial nerve along a second portion of the subject's body.Optionally, a sensor may be positioned over a corresponding muscle todetect muscle stimulation or twitching resulting from nerve stimulation.Optionally, the electrical conduction is detected along a second portionof the subject's body which is different from the first portion of thebody. Optionally, the sensor in the form of a microneedle patch. Incertain variations, the sensor may be positioned behind a subject's kneeto detect the electrical conduction along the afferent posterior tibialnerve or on another portion of a patient's leg or foot. In othervariations, the sensor may be positioned within or along a housing alongwith the one or more conductive coils.

Where a sensor is used a signal is received from the sensors and thesignal is indicative of the electrical conduction of the posteriortibial nerve. The current may be adjusted or varied using a controllerwhich is in communication with the energy generator. Adjustments may bemade in response to the nerve or muscle stimulation detected by theconductive sensor, in order to optimize or ensure adequate treatment ofpremature ejaculation by achieving the appropriate level of conductanceand appropriate level of nerve or muscle stimulation. Appropriate levelsfor current, frequency, magnetic field, treatment duration, etc., arelevels that result in an observed or detected reduction or prevention ofsymptoms associated with premature ejaculation. Treatment could also beadministered and the appropriate levels and parameters achieved throughobserving or detecting, reduction or prevention of symptoms where asensor is not used. Examples of these symptoms include but are notlimited to: ejaculation that frequently occurs within one minute or lessof penetration; the inability to delay ejaculation on penetrations; orpersistent or recurrent ejaculation with minimal stimulation before, onor shortly after penetration.

In certain variations, the amplitude, frequency, direction of agenerated magnetic field, electrical or magnetic stimulus, or firingsequence of the coils or microneedles making up the microneedle arraymay be adjusted. Optionally, the current may be varied according to amuscular response in the patient. Thus, to treat premature ejaculation,the magnetic field or electrical stimulus is applied to a subject orpatient until the desired effects (e.g., reduction of symptoms) areachieved.

Exemplary treatment parameters for treating various conditions, e.g.,urinary incontinence, using the systems and methods described herein mayinclude the following. Operation of a conductive coil at about 10 to 20hertz generating, a magnetic field of about 0.25 to 1.5 tesla, where thecoil is administered to a patient for a duration of about 30 minutes/dayor 30 minutes per week, depending on the severity of the symptoms, untilthe symptoms subside. The above treatment parameters or variations onthe parameters may be used for treatment of urinary incontinence, fecalincontinence, restless leg syndrome, or premature ejaculation or otherconditions. For example, the coil may be operated at various parameterranges falling with the following ranges: about 5 to 100 hertz, about 1to 10 tesla, for about 15 minutes to 2 hours per day or week. Intreating premature ejaculation, a patient may receive treatment about 4to 10 hours prior to intercourse. A maintenance phase of treatment,after the initial treatment, may vary for various conditions. Forexample, the maintenance phase may require application of the systemsand methods described herein at the parameters described herein for 30minutes/week or 30 minutes/month. Any treatment parameter may be variedor modified based on the effect on the patient or sensor or patientfeedback regarding stimulation, until the desired result of treating orpreventing a condition is achieved.

In certain variations, as shown in FIGS. 29a-29d , energy emittingdevice may include a controller 289 and a foot cradle 290. Foot cradle290 may include vertical foot plate 291, and horizontal foot plate 292,where each plate can be adjusted using vertical foot plate knob 293 andhorizontal foot plate knob 294. One or more EMG plugs 295 are provided.An air core coil 297 or other type of coil is provided. A display screen2% may also be provided along with power cord 298. The display screen 2%can display a variety of information to the user and/or practitionersuch as the level of power or current applied, treatment time,temperature of the cradle device, detected current levels and/orphysiological parameters, etc., to facilitate effective and efficienttherapeutic treatment. The information can be used to vary or adjust thecontroller to ensure that adequate conduction of a target nerve, e.g.,posterior tibial nerve 220 or muscle stimulation occurs and an adequateand accurate dosage of treatment is being received. Controls may also beincluded to affect the following: power, field strength, frequency,pulse, start/pause and cancelation of therapy as shown) or otherparameters one of skill in the art would find necessary or useful tocontrol or monitor. In certain variations, a sensor may be connected,connected or in communication with the foot cradle or other energyemitting apparatus, controller, housing, conductive coils, ormicroneedle patch.

In certain variations, as shown in FIGS. 30A-30B, an energy emittingdevice may include a controller and a knee support or knee cradle. Thecradle may be configured to provide the conductive coil in proximity tothe popliteal fossa or area directly behind the knee. In certainvariations, the knee cradle may be configured to cradle or surround atleast a portion of the knee or substantially the entire knee withoutplacing direct pressure on the popliteal fossa, thereby minimizing oravoiding, venous thrombosis. In one variation, the device may beutilized while the knee is in the flexed position (FIG. 30A). In anothervariation, the device may be utilized while the knee is in a non-flexedposition (FIG. 30B).

In certain variations, the energy emitting device, e.g., foot support orcradle, knee support or cradle, etc., includes a conductive coilpositioned such that a target nerve is automatically targeted. Theconductive coil is configured, sized and positioned within the devicesuch that the generated magnetic field may encompass and stimulate thetarget nerve in any patient based on the target nerve's anatomicallocation, thus providing automatic targeting of the nerve in any patientonce the patient positions a particular body portion in the device.

In certain variations described herein, sensors may detect voltage orcurrent and may be connected, coupled, wirelessly connected or coupledor otherwise in communication with housing, conductive coils,microneedle patch, energy emitting apparatus, energy generators, orelectrode needles and/or controller using, a variety of methods ortechniques known in the art. In various variations described herein,housings, conductive coils, microneedle patches, energy emittingapparatus, energy generators, or electrode needles may be connected,coupled, wirelessly connected or coupled or otherwise in communicationwith each other, controllers or sensors, using a variety of methods ortechniques known in the art.

Coils used in any of the variations described herein and illustrated inthe corresponding figures may take on a variety of shapes, sizes, andconfigurations. For example, a coil may be shaped as a spiral (as shown)or have a simple helical pattern or be a figure eight coil, a four leafclover coil, a Helmholtz coil, a modified Helmholtz coil, or may beshaped as a combination of the aforementioned coil patterns.Additionally, other coil designs beyond those mentioned hereinabovemight be utilized as long as a magnetic field is developed that willencompass a target nerve.

The coils may have a variety of dimensions and configurations. Incertain variations, a coil may have a central aperture. The diameter ofthe aperture may range from about 0.5 inch to 2 inches or 1 inch to 1.5inches or the aperture may have a diameter of about 1 inch. The diameterof the coil body may vary. For example, the diameter may range fromabout 3.0 to about 7 inches or from about 4 to about 5 inches or thediameter may about 4.5 inches. The coil body may include any suitablenumber of turns. For example, the coil body may include from about 2 toabout 25 turns or from about 10 to about 20 turns or 14 to 17 turns. Theadjacent turns may be spaced apart from each other, providing a gapthere between. An end or cross section of a turn may have variousdimensions. For example, the end or cross section may have a height thatis greater than its width. An end or cross section of a turn may have aheight ranging from about 1 to 5 cm or from about 10 mm to 51 mm (about0.3 inches to 2 inches) or about 25 mm to 40 mm (about 1 inch to 1.5inches) or about 12 mm to 40 mm (about 0.5 inch to 1.5 inch) or about0.5 inch to 2 inch. The end or cross section of the turn may have awidth ranging from about 0.5 mm to about 5 mm (about 0.019 inch to 0.19inch) or from about 1 mm to about 2 mm (about 0.03 inch to 0.07 inch) orabout 0.2 mm to about 1.6 mm (about 0.01 inch to 0.06 inch). The aboveare all exemplary dimensions, where other dimensions are alsocontemplated depending on the use and configuration of a device.

In certain variations, a system or device for electromagnetic ormagnetic induction therapy may include one or more conductive coilsdisposed within or along an applicator. The coil may be configured togenerate an electromagnetic or magnetic field focused on a target nerve,muscle or other body tissue positioned in proximity to the coil. Thesystem may also include one or more sensors. The sensor may beconfigured to detect electrical conduction in the target nerve or todetect stimulation of a muscle or other body tissue. The sensor may alsodetect a muscular response caused by an electrical conduction in atarget nerve. The sensor provides feedback about the efficacy of theapplied electromagnetic or magnetic induction therapy. Optionally, auser may provide such feedback based on detection by the user, with orwithout the use of a sensor. The system may also include a controllerwhich is in communication with the sensor. The controller may beadjustable to vary a current through the coil in order to adjust themagnetic field focused upon the target nerve based on feedback from thesensor or user. The various systems or devices described herein may beutilized with or without a sensor.

A variety of electromagnetic or magnetic induction applicators designedor configured to stimulate various portions of a patient's body fortreating various conditions are contemplated herein.

FIG. 31A illustrates a variation of a hand or arm applicator 310. Thehand or arm applicator 310 may be ergonomic or contoured to a hand orarm to be positioned relative to or in proximity to a hand or arm togenerate an electromagnetic or magnetic field focused on a target nerve,muscle or other tissue within the hand or arm. Optionally, a hand or armapplicator 310 may be designed to stimulate the entire hand or arm of apatient, for example, where the patient has limited or reduced nerveinnervation to those portions of the body.

FIG. 31B also illustrates a variation of a foot, knee or leg applicator320. The foot, knee or leg applicator 320 may be ergonomic or contouredto a foot, knee or leg to be positioned relative to or in proximity to afoot, knee or leg to generate an electromagnetic or magnetic fieldfocused on a target nerve, muscle or other tissue within the foot, kneeor leg. Optionally, a foot, knee or leg applicator 320 may be designedto stimulate the entire foot, knee or leg of a patient, for example,where the patient has limited or reduced nerve innervation to thoseportions of the body.

FIG. 32 illustrates a variation of a stand alone back applicator 330.The back applicator 330 may be ergonomic or contoured to the back or toa specific area of the back to be positioned relative to or in proximityto the back to generate an electromagnetic or magnetic field focused ona target nerve, muscle or other tissue within the back. A backapplicator 330 may be aligned along the spine or positionable inproximity to the spine. The back applicator 330 may be utilized tostimulate nerve offshoots, dorsal ganglion, the spinal cord itself orany other nerve in the body, to treat various conditions, for example,to treat atrophy or paralysis.

The back applicator 330 may include several coils, which may be pulsedintermittently. In certain variations, a sensor may be placed on musclein dermatome to provide feedback to ensure stimulation of the properdorsal root ganglion or vertebral body. The sensor may provide feedbackto channel energy or current to the proper or effective coil anapplicator, e.g., in an applicator having multiple coils.

FIG. 33 shows a system including a corded back applicator 340, a sensor342 and a logic, controller 344. Various sensors may be utilized, e.g.,a three lead EMG, other EMG electrode, a microneedle electrode, or anysensor for detecting physiologic changes associated with nerve firingand/or muscle contraction. The sensor 342 provides feedback which may beused to monitor and/or control therapy. The sensor 342 may be used toposition or optimize therapy in a clinic or home healthcare setting. Theapplicator 340 may or may not contain a pulse generator and/or logiccontroller circuitry. FIG. 33 shows the logic controller 344 and pulsegenerator as a separate unit. The logic controller may optimize therapyand minimize energy usage or overheating based on feedback from sensor342. Optionally, the logic controller 344 may be incorporated into anapplicator. The logic controller 344, whether separate from theapplicator or incorporated in the applicator, may be controlled based onfeedback from the sensor.

FIG. 34 shows a system including a whole back applicator 350, a sensor352 and a logic, controller 354. One or more back applicators 350 may beprovided. One or more applicators 350 may include automated therapytargeting. The applicators 350 may include multiple coils, which can befired sequentially to stimulate the entire spine or chain of dorsal rootganglion (with or without user or sensor feedback) for osteoarthritistherapy, back or neck pain therapy, prevention of muscular atrophyand/or nerve recovery after paralysis, stroke, or after suffering othernerve damaging conditions. In one variation, one or more applicators 350may include multiple coils fired sequentially in order to determine theoptimal coil for stimulation based on user or sensor feedback. Once theoptimal coil is determined, that coil may be selected and used for theremainder of the therapy. In another variation, one or more applicatorsmay include one or more coils that are slidable adjustable or movablewithin the applicator housing. The coils may be moved within theapplicator housing to treat a large area and/or to be focused on theoptimal treatment zone based on feedback from the user and/or feedbackfrom the sensor.

FIG. 35 shows a variation of a back applicator 360 which may bepositioned in proximity to or aligned along a spine. The back applicator360 may have ergonomic features or may be placed in proximity to a spineor a spine may be positioned in proximity to the applicator 360. Theapplicator 360 may include several coils that are pulsed intermittently.As shown in FIG. 35, the back applicator 360 or focused back applicatormay be held on a patient by an ergonomic positioning element 361 (e.g. abelt) and may be fit such the cervical, thoracic, lumbar, sacral and/orlumbosacral curvatures hold the back applicator 360 in the optimalposition. The applicator 360 may be located anywhere along thepositioning element 361 depending on the individual and area to bestimulated. Optionally, a sensor lead 362 may be placed over musculatureor along a nerve excited by activation of the applicator 360. In onevariation, a coil power line 365 for supplying power or current from thelogic controller 364 to coils positioned in the applicator 360 mayinclude fluid cooling, e.g., air or liquid cooling.

FIG. 36 shows an applicator 366 designed or Configured to generate amagnetic field focused on a target nerve responsible for phantom orneuropathic pain. The applicator 366 or phantom pain therapeuticstimulator unit may be utilized to treat phantom pain or neuropathicpain, to provide phantom pain or neuropathic pain therapy. Theapplicator 366 may be ergonomic or contoured to be positioned relativeto or in proximity to a nerve responsible for phantom or neuropathicpain.

FIG. 37 shows a facial neuralgia applicator 380. Facial neuralgiaapplicator 380 may be may be ergonomic or contoured to a face or head tobe positioned relative to a face or head to stimulate a nerveresponsible for facial neuralgias. The applicator 380 may be designed orconfigured to be positioned relative to, in proximity to or on apatient's face or head and to generate a magnetic field focused onnerves responsible for facial neuralgias, e.g., the trigeminal nerve, totreat facial neuralgia. Optionally, a sensor may be positioned along afacial nerve to ensure adequate therapy and to provide feedback, e.g.,to a logic controller, regarding nerve conduction or body stimulation.

In certain variations applicator may be designed to ergonomically targetcommon nerves responsible for common neuralgias in order to treat suchneuralgias. In other variations, an applicator may be used for treatingneuralgias virtually anywhere on a patient's body, including in deepnerves due to the ability of magnetic fields generated by the applicatorto penetrate painlessly. In certain variations, an applicator may bedesigned to generate a magnetic field focused on a target nerve to treatcentral or peripheral neuralgias.

FIG. 38 shows a depression applicator 386 which is designed orconfigured to be positioned relative to, in proximity to or over afrontal cortex. The applicator 386 may be ergonomic or contoured to ahead to be positioned relative to a head to stimulate the frontalcortex. The applicator 386 may generate an electromagnetic or magneticfield focused on the frontal cortex to treat depression. A sensor may bepositioned in the offshoots of the motor cortex. The sensor may providefeedback to ensure appropriate placement of the applicator 386 or coil.In one variation, the applicator 386 may include a therapeutic coil anda targeting coil (e.g., a small non-treatment coil), which may bepositioned a certain distance behind the therapeutic coil, e.g., about 5cm behind the therapeutic coil. When firing of the targeting coil issensed by the sensor (or user-feedback), the therapeutic coil may bepositioned in the correct or optimal position over the frontal cortexfor depressive therapy.

FIG. 39 shows a migraine applicator 390 which is designed or configuredto be positioned relative to, in proximity to or over an occipitalnerve. The applicator 390 may be ergonomic or contoured to a face orhead to be positioned relative to a face or head to stimulate theoccipital nerve. The applicator 390 may generate an electromagnetic ormagnetic field focused on the occipital nerve to halt, prevent or treatmigraines. The applicator 390 may have an ergonomic design to ensureappropriate placement over the occipital nerve. In one variation, theapplicator 390 may be a single (or few) pulse device. The applicator 390may be in a portable format. The applicator 390 may also be without anysignificant cooling features. Optionally, the applicator 390 may havecooling features. In another variation, an applicator may be a multiplepulse, higher frequency device. Such an applicator may include coolingfeatures, where cooling is provided by utilizing liquids or airflow,such as rapid airflow to cool the coils or applicator.

FIG. 40 shows a variation of an applicator 396 in the form of astimulatory coil platform which may be ergonomic and contoured to aknee. The applicator 396 is configured to be positioned relative to orin proximity to a knee or the applicator 396 is configured such that aknee may be positioned relative to or in proximity to the applicator396. The applicator 396 may be configured to generate an electromagneticor magnetic field focused on the popliteal nerve for peripheral nervestimulation to treat various conditions, e.g., overactive bladder,neuropathic pain or restless legs. In one variation, a stimulatory coilmay target an area behind a patient's knee or the popliteal fossa, andthe knee may be rested on a stimulatory coil platform applicator in anyposition.

In certain variations, an applicator may include one or two (bilateral)magnetic field generating coils, which may be positioned around the kneewhen the patient is in a sitting, standing or prostrate position. Incertain variations, a pulse generator or logic controller 397 may sendenergy through one or more coils to create an electromagnetic ormagnetic field. The applicator or coils may generate stimulatory ornon-stimulatory fields. Sensor or user feedback may provide feedback tologic controller to optimize therapy, e.g., with the stimulatory fields.An applicator may be utilized for generating magnetic fields focused onan area of a patient's body, e.g., the knee, to treat various orthopedicindications, e.g., knee pain or osteoarthritis. An applicator may beutilized for generating magnetic fields focused on a area of a patient'sbody to treat various non-orthopedic indications, via, e.g., peripheralnerve stimulation.

FIGS. 30A-30B, show a variation of an applicator 400 which may beutilized for popliteal nerve stimulation and/or treatment of the knee.The applicator may be designed or configured to generate anelectromagnetic or magnetic field focused on the popliteal nerve forpopliteal nerve stimulation or on the knee for treating osteoarthritis.The applicator is configured to be positioned relative to or inproximity to a knee or the applicator is configured such that a knee maybe positioned relative to or in proximity to the applicator. A leg mayrest on the applicator coil or be positioned above it. Optionally, asshown in FIG. 30B, a foot rest 104 may be provided for holding up afoot.

FIG. 41 shows a system including a variation of all ergonomic backapplicator 410 held on a patient's body by an ergonomic positioningelement 411 in the form of a shoulder harness. A sensor 412, and alogic, controller 414 are also provided. The applicator 410 may includevarious positioning elements 411, e.g., a shoulder harness, an uppertorso garment, or an ergonomic back-countered plate. The applicator 410may be stimulatory or non-stimulatory. In another variation, anapplicator may be rested on a seat or chair such that a stimulatory coilreliably overlies the area of the patient's body requiring stimulation.In certain variations, one or more coils may be fixed on the applicator(requiring prior targeting by a healthcare provider or patient) or oneor more coils may move freely within or along the applicator and may belocked into position when the desired or optimal position is located.Coils may also move automatically in order to optimize targeting of thecoil based on sensor or user feedback. The system may be incorporatedinto a single unit or, as illustrated, have at least two componentsincluding a separate logic controller.

For any of the applicators described herein, such applicators mayinclude one or more of the following features. The applicators may beergonomic or contoured to the specific region of the body or anatomy towhich the applicator will be delivering stimulation. The applicators maybe configured or designed to be positioned relative to, on, around, orin proximity to a specific region of the body or the applicators may beconfigured or designed such that the targeted region of the body may bepositioned relative to, on, around or in proximity to the applicator.The applicators may be openable or adjustable to allow for insertion orentrance of the targeted body part or anatomy into the applicator or toallow for placement of the applicator onto or around the targeted bodypart or anatomy. The applicators may be flexible or ergonomic toaccommodate nearly any type of body habitus. In certain variations, asolenoid-type coil may incorporated into an applicator for deliveringPEMF stimulation directly to the targeted areas or regions of a body. Incertain variations, any of the applicators described herein mayapproximate the respective targeted body area or anatomy or theapplicators may be designed such that the body region or targetedanatomy may approximate the applicator.

In certain variations, any of the applicators or systems describedherein may be used to provide electromagnetic or magnetic inductiontherapy with or without a sensor.

In certain variations, electromagnetic stimulating devices orapplicators for providing stimulation to tissues of the human body,including nerves, muscles (including superficial and deep muscles),and/or other body tissues for the treatment of various conditions,including, e.g., chronic and acute pain, are provided.

The devices may utilize an inductive coil encased within an ergonomic,body-contoured applicator to target specific regions of the body. Thecoils may be designed to target peripheral nerves throughout the bodythat have been implicated or involved in pain syndromes.

The various designs and configuration of the devices described hereinallow for easier application, more consistent therapy and home use whiletargeting anatomic regions with therapeutic pulsed electromagneticfields. The fields may also be delivered or applied in an intermittentmanner to allow for convenience and ease of use while providing adurable benefit. With intermittent external stimulation by pulsedelectromagnetic or magnetic fields, a nerve or other tissues may bestimulated in manner that provides a continued and lasting effect onnerve, muscle or tissue function, without habituation.

The electromagnetic or magnetic induction stimulation devices describedherein substantially improve the state of the art electromagneticstimulation technology and may incorporate the delivery of PEMF therapyinto a user friendly, body contoured applicator. In certain variations,a delivery system for PEMF therapy may include elements such as, e.g.,(1) an ergonomic, body contoured applicator which provides forrepetitive application and consistent therapy onto the same body area.The applicator may be coded with clear markings to facilitate repetitiveand consistent therapy onto the same body area; (2) the use of a sensorto provide feedback that stimulation is occurring effectively; and/or(3) the use of intermittent stimulation to effectively treat variousconditions, e.g., chronic pain, without habituation. These elementsindividually or the various combinations of these elements have providedfor an easy to use, ergonomically designed system that has applicationswithin a host of clinical and home ease of use health applications.

In certain variations, an electromagnetic or magnetic inductionstimulation device able to provide stimulation to tissues of the humanbody, including nerves, muscles (including superficial and deepmuscles), and/or other body tissues without significant discomfort tothe patient is provided. Conductive stimulating coils may be encased inan ergonomic, body contoured applicator that is coded with clearmarkings to provide for repetitive application and consistent therapyonto the same body area. The design of the applicator allows for ease ofuse and also for the targeting of anatomic regions to be exposed to theimpulses of the PEMFs. The electromagnetic stimulating device mayprovide PEMF in a manner that is patient user friendly and the devicemay be portable. The device may be utilized in a hospital, an outpatientclinic, a therapist's office, or at a patient's home.

In certain variations, an electromagnetic or magnetic inductionstimulation device may stimulate regions of the body to treat conditionsrequiring both maximal stimulation (i.e., sufficient to causecontraction of muscle fibers and firing of nerves) as well as submaximalstimulation (which will be sufficient to provide therapy but not tocause contraction of muscle fibers).

The electromagnetic or magnetic induction or stimulating devicesdescribed herein may be utilized for various indications. Theindications may be divided into maximal and submaximal categories, inwhich the former requires significantly higher levels of inductingcurrent than the latter. The maximal applications of the device include,but are not limited to: Non-invasive stimulation (intermittent orcontinuous) of the peripheral nervous system for treating chronic pain;stimulation of a nerve for the up- or down-regulation of hormones orcellular proliferation; treatment and/or prevention of atrophy, whichwould be therapeutic during recovery after an individual sustains afracture, experiences paralysis of a limb or other body part, orundergoes surgery, such as ACL repair in the knee; treatment ofneurogenic or overactive bladder and bowel; and stimulation of thecentral nervous system to alter neural pathways or up/down-regulate theaforementioned factors.

Additional applications of the devices include but are not limited to:treatment of neuropathic pain (e.g., phantom pain in limbs or otherneurologic pain) or orthopedic pain (back and neck pain or skeletalrelated pain); treatment of overactive bladder and bowel; and treatmentof arthritis and/or orthopedic conditions.

In certain variations, a device is provided for delivering PEMFstimulation to selective anatomic regions of the body, utilizing anergonomic applicator designed to facilitate accurate and targeteddelivery of therapy. The applicator may be coded with clear or solidmarkings to provide for repetitive application and consistent therapyonto the same body area of the body. This design may facilitate theplacement of the device for the stimulation of key nerves, muscles,and/or body tissues.

In certain variations, a device is provided which may be utilized toelectromagnetically stimulate selective nerves, muscles, and/or bodytissues, where the device is user friendly and capable of being usedeven by an unskilled patient in a home healthcare setting.

In certain variations, a device is provided to electromagneticallystimulate selective nerves, muscles, and body tissues to provideconsistent therapy, with an ergonomic applicator targeting key nervesand eliminating the requirement for a highly trained operator tomanipulate the device.

In certain variations, an electromagnetic or magnetic induction systemor device may be configured or designed to provide intermittentlyapplied pulsed magnetic fields in the treatment of chronic conditions,such as pain. For example, a device as described herein may provideshorter, intermittent stimulation to treat chronic pain or other chronicconditions. The delivery of pulsed magnetic fields may have a continuedand lasting effect on nerve function in treating conditions, such as,overactive bladder as well as other chronic neurological and orthopedicconditions such as neuropathic pain, restless legs and orthopedic pain(e.g., spinal pain, back pain, etc.)

In certain variations, intermittent pulsed magnetic fields may beutilized for the treatment of chronic and acute non-orthopedicconditions such as neuropathic pain, phantom pain and chronicneuralgias, as well chronic and acute orthopedic conditions, such asback pain and neck pain. The therapeutic magnetic fields may be appliedfrequently (e.g., several times a day) or less frequently (e.g., once aweek or once a month) depending on the durability of the effect for theindividual patient. Treatment involving the use of magnetic fields doesnot require surgery or needles to stimulate a nerve. Also, the deliverof intermittent pulsed magnetic fields prevents the nerve from becominghabituated to the stimulator signal by ensuring that there are periodsduring which the nerve is not subjected to the stimulatory signal.Accordingly, the electromagnetic or magnetic induction systems ordevices described herein may provide unparalleled ease of use,non-invasiveness, reliability of therapy based on sensor feedback and/orergonomic targeting, and/or a lack of habituation due to intermittentstimulation provided by certain systems and devices.

In certain variations, the electromagnetic or magnetic induction systemsor devices described herein may incorporate an air-cooled coil whereinthe air coolant, e.g., liquid or air, is drawn through and/or in betweenthe turns of the inductive coil, in direct contact with conductivesurfaces of the coil. Drawing air or other fluid through the coilprevents the coil from heating up to the degree that could damage thecoil and the electronics of a device, or expose the patient to excessivetemperatures.

In certain variations, the systems and devices described therein may beutilized to stimulate nerves for a variety of conditions, including,e.g., atrophy prevention, nerve repair/regeneration, neuromodulation,chronic pain, up or down regulation of hormones, restless legs, phantompain, etc. The systems and devices may also be used to stimulate musclesand/or other body tissues to accelerate tissue healing, regenerationand/or growth.

In certain variations, the electromagnetic or magnetic induction systemsor devices described herein and other implantable or extracorporealdevices may allow for the automatic adjusting of nerve stimulation basedon feedback.

In one variation, an extracorporeal or implantable device, e.g., any ofthe electromagnetic or magnetic induction devices described herein, apacemaker, defibrillator, or nerve stimulator, may include a featurethat allows for automatic adjustment of nerve stimulation based onfeedback provided by a sensor or user. This feature may minimize painand power usage while ensuring optimal therapy delivery. A device mayinclude a stimulator and a sensing component. The stimulator may beautomatically adjustable based on feedback from the sensor up to amaximal (safe) threshold. Each therapy may start with lower poweredpulses, followed by increasing power pulses until the sensor detectsstimulation. The algorithm allows for the minimal amount of power to beused and allows for automatic adjustment of power settings as conditionschange.

In one variation, an implantable device may include a sensor, such thatthe device can stimulate tissue or nerves and sense stimulation at thesame site. For example, the sensor may provide feedback to theimplantable device regarding nerve conduction at the site ofstimulation. As fibroses develops around an implant, at the site ofstimulation, the feedback will indicate whether a target nerve is nolonger being effectively stimulated due to the fibroses, which willcause the power or level of stimulation to increase or decrease, as isnecessary, to effectively stimulate the target site and overcome anyobstruction due to fibroses. As fibroses occurs around an implant, apatient need not report back to a physician or other operator foradjustment of the stimulatory power of the device. The device willautomatically adjust the stimulatory power or level based on sensingstimulation of the target nerve or tissue. This eliminate the guessworkinvolved by the user in monitoring their therapy one day at a time ontheir own, as they notice the effect of the therapy wear off. This alsoeliminates the risk of the user being exposed to unnecessarily highpower levels that might otherwise by set in order to minimize frequentreturn visits to a physician or operator for adjustments.

FIGS. 42A and 42 show an example of how the amount of stimulatory powerrequired to achieve a desired stimulus may be automatically adjusted asa result of fibroses, according to the above described feature.According to FIG. 42A, after the initial implant of the device, thelevel of stimulatory power is increased until stimulation of the targetnerve or tissue is sensed (indicated by square box at, e.g., about 10mV). An effective stimulatory therapy may then be delivered. Accordingto FIG. 42B, after fibroses sets in, in order to maintain the desiredlevel of stimulation to provide an effective stimulatory therapy, thelevel of stimulatory power is increased until stimulation of the targetnerve or tissue is sensed (indicated by square box, e.g., at 20 mV).According to the example in FIG. 42B, the presence of fibroses requiredan increase in the stimulatory power level to deliver an effectivestimulatory therapy.

The automatic adjustment feature based on sensor feedback may beutilized in any stimulator or non-stimulatory implant or extracorperaldevice, where the device incorporates a sensor capable of detecting thedesired stimulus and a feedback loop capable of automatically adjustingparameters (e.g., power, frequency, etc.) to ensure appropriatestimulation.

In certain variations, the electromagnetic or magnetic induction systemsor devices described herein and other implantable or extracorporealdevices may include a feature that allows for automatic targeting ofcoils.

A device may include multiple inductive coils or one or more movableinductive coils. The device may also include a sensor based feedbackalgorithm. In one variation, the device includes a targeting or movablecoil which may be positioned over or in proximity to a patient's body ata site that elicits a response that can be sensed automatically ordetected by a user. Once this response is detected, the coil may eithermove to its stimulation position, or in the event that a smalltargeting, coil is used, the therapeutic coil ma already overlie thetreatment area. Once the response is detected, the therapy mayautomatically begin.

In one example, relating to the treatment of depression, the motorcortex is stimulated until the thumb is seen to move. The coil may thenbe advanced, e.g., about 5 cm. to about 5 inches, forward to a positionover the frontal cortex. This feature eliminates the guesswork that mayotherwise be involved in moving or positioning a coil, and automatestherapy based on user feedback or EMG senor or other sensor feedback,e.g., over a thumb.

FIG. 43A shows an example of a device 420 positioned on a skull. Thedevice includes a treatment coil 422 and a targeting coil 423. Thetreatment coil 422 may be positioned by EMG detection with targetingcoil 423 stimulation, where the targeting coil may not move.

In another variation shown in FIG. 43B, an ergonomic fixture orapplicator 430 (e.g., a helmet) may be worn and a coil 432 positioned onthe applicator may slide or move from ns targeting position to itstherapeutic position automatically or by user intervention.

The feature that allows for automatic targeting of coils may be utilizedin any device designed to stimulate nerve, body or other tissues withstimulatory or sub-stimulatory fields in which the device may betargeted based on a detectable signal or response.

Other conditions that may be treated utilizing the variouselectromagnetic or magnetic induction stimulation systems and methodsdescribed herein include but are not limited to: pelvic pain,interstitial cystitis, fibromyalgia, chronic fatigue and preterm labor,pain syndromes, Irritable Bowel Syndrome, Vulvodynia, Herpetiucneuralgia, trigeminal neuralgia and Myofascial pain.

EXAMPLES

The following Examples are provided for illustration, not limitation.One with skill in the art would be able to use these examples asguidelines for making and using comparable devices.

In each example, intermittent therapy should be applied andsymptoms/scores tracked for a minimum of 6 weeks in order to determinethe full extent of the therapies effect.

Example 1: Empirical Testing of Efficacy in the Treatment of NeuropathicPain

The optimal stimulus intensity for neuropathic pain treatment; theoptimal application parameters, i.e. frequency of stimulation, durationof treatment, location of stimulatory coils in each disposable array ofcoils; and the optimal coil diameter/placement within the strays can bedetermined using, the following experimental protocol: Before, duringand after treatment, patients will report scores of neuropathic painafter weekly stimulation over a minimum of 6 weeks.

Example 2: Empirical Testing of Efficacy in the Treatment ofNeuromuscular Pain

The efficacy of neuromuscular pain treatment can be tested by monitoringpatient reported pain scores. A standardized scale may be utilized and,when feasible, local biopsy and blood tests can be useful in determiningthe impact of the therapeutic fields on circulating factors and localmediators. The optimal pulse amplitude, duration, site of stimulationwill be assessed based on reported pain scores and diagnostic tests.

Example 3: Empirical Testing of Efficacy in the Treatment of OrthopedicConditions (i.e., Arthritis, Back Pain and Neck Pain)

The efficacy of arthritis treatment can be tested by monitoring patientreported functionality scores. A standardized subjective functionalityscale may be utilized and, when feasible, local biopsy may be useful indetermining the impact of the therapeutic fields on the cartilage andarthritic regions treated. As cartilage destruction is a well-studiedside-effect of arthritis, reduction of this degeneration will be avaluable marker for efficacy of therapeutic treatments. The optimalpulse amplitude, duration, site of stimulation will be assessed based onreported functionality scores and diagnostic tests. Pain scores may alsobe measured to determine the device's impact on orthopedic conditionssuch as back pain, neck pain, etc. A standardized pain scale may be usedbefore and after treatment to determine potential benefit.

It is also contemplated that any of the energy emitting systems ordevices described herein can be used with or without a sensor fordetecting conduction of a stimulated nerve or muscle of tissuestimulation resulting from the electromagnetic or magnetic field,generated by the conductive coil and delivered to a patient or anelectrical stimulus delivered to a patient. Also, in any of the abovevariations, a controller may optionally be connected, coupled, integralto or otherwise in communication with the conductive coils and/or thesensor. Optionally, the sensor may be connected, coupled, integral to orotherwise in communication with the conductive coil.

Each of the individual variations described and illustrated herein hasdiscrete components and features which may be readily separated from orcombined with the features of any of the other variations. Modificationsmay be made to adapt a particular situation, material, composition ofmatter, process, process act(s) or step(s) to the objective(s), spiritor scope of the present invention.

Methods recited herein may be carried out in any order of the recitedevents which is logically possible, as well as the recited order ofevents. Furthermore, where a range of values is provided, everyintervening value between the upper and lower limit of that range andany other stated or intervening value in that stated range isencompassed within the invention. Also, an optional feature of theinventive variations described may be set forth and claimedindependently, or in combination with any one or more of the featuresdescribed herein.

All existing subject matter mentioned herein (e.g., publications,patents, patent applications and hardware) is incorporated by referenceherein in its entirety except insofar as the subject matter may conflictwith that of the present invention (in which case what is present hereinshall prevail). The referenced items are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such material by virtue of prior invention.

Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin the appended claims, the singular forms “a,” “an,” “said” and “the”include plural referents unless the context clearly dictates otherwise.It is further noted that the claims may be drafted to exclude anyoptional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like in connection with the recitation of claim elements,or use of a “negative” limitation. Unless defined otherwise, alltechnical and scientific terms used herein have the same meaning ascommonly understood by one of ordinary skill in the art to which thisinvention belongs.

This disclosure is not intended to be limited to the scope of theparticular forms set forth, but is intended to cover alternatives,modifications, and equivalents of the variations described herein.Further, the scope of the disclosure fully encompasses other variationsthat may become obvious to those skilled in the art in view of thisdisclosure. The scope of the present invention is limited only by theappended claims.

What is claimed is:
 1. A method, comprising: applying an electrode patchto skin such that the electrode patch is disposed on an outer surface ofthe skin and the electrode patch is electrically coupled with acontroller unit, the controller unit including a pulse generator;electrically coupling a percutaneous electrode to the controller unit,the percutaneous electrode having an end for inserting in proximity to atibial nerve, or a branch thereof, of the patient; inserting the end ofthe percutaneous electrode into the skin in proximity to the tibialnerve, or a branch thereof, of the patient; and activating the pulsegenerator such that current pulses flow along the tibial nerve, orbranch thereof, by passing between the electrode patch and thepercutaneous electrode, the current pulses configured to treatoveractive bladder.
 2. The method of claim 1, wherein inserting the endof the percutaneous electrode comprises inserting the end near or at anankle of the patient.
 3. The method of claim 1, further comprisingdetecting a muscular response caused by an electrical conduction orstimulation of a nerve, muscle, or body tissue.
 4. The method of claim1, wherein activating the pulse generator comprises activating for aduration of about 30 minutes per week to treat the patient.
 5. A method,comprising: positioning a transcutaneous electrode on skin of a patientin proximity to a tibial nerve, or a branch thereof; inserting an end ofa percutaneous needle electrode through the skin in proximity to thetibial nerve, or a branch thereof, the percutaneous needle electrodeincluding a wire disposed opposite the end; securing a controller unitto the transcutaneous electrode such that the controller unit iselectrically coupled to the transcutaneous electrode, the controllerunit including a pulse generator; connecting the wire of thepercutaneous needle electrode to the controller unit for electricallycoupling the percutaneous needle electrode to the controller; andactivating the pulse generator such that current pulses flow along thetibial nerve, or a branch thereof, by passing between the transcutaneouselectrode and the percutaneous needle electrode, the current pulsesconfigured to treat overactive bladder.
 6. The method of claim 5,wherein inserting an end of the percutaneous needle electrode comprisesinserting the end near or at an ankle of the patient.
 7. The method ofclaim 5, further comprising detecting a muscular response caused by anelectrical conduction or stimulation of a nerve, muscle, or body tissue.8. The method of claim 5, wherein activating the pulse generatorcomprises activating for a duration of about 30 minutes per week totreat the patient.